Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main objective of this study is to assess the safety, tolerability and efficacy of ATI-50002 Topical Solution, 0.46% in subjects with non-segmental facial vitiligo.
This is a multicenter, open-label study designed to evaluate the safety, tolerability and efficacy of ATI-50002 Topical Solution 0.46% in subjects with non-segmental facial vitiligo. Subjects will be required to have a clinical diagnosis of non-segmental facial vitiligo effecting at least 0.25% of total body surface area (TBSA) (excluding upper and lower eyelids, mucosal lip areas, and forehead and chin areas covered by the stereotactic positioning device for photography) with at least one area of the face with normal pigmentation. Twenty-four eligible subjects will receive ATI-50002 Topical Solution, 0.46%, BID for 24 weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATI-50002 Topical Solution | Experimental | ATI-50002 topical solution, high dose active, twice-daily, 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATI-50002 topical solution | Drug | Topical Solution administered twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline to Week 24 | Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 24. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Baseline to 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 48 | Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 48. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Subject with evidence of poliosis (white hairs) in > 50% of their facial vitiligo lesions.
Subject with total facial depigmentation.
Subject with spontaneous ongoing repigmentation (documented based on the subject's reporting in the last 3 months).
Subject who has segmental vitiligo.
Subject who has failed phototherapy. Failed phototherapy is defined as failure to achieve satisfactory repigmentation following adequately delivered phototherapy as determined by the investigator.
Subject currently has, or has a history of, skin disease (e.g., psoriasis, seborrheic dermatitis, etc.) that, in the opinion of the investigator, would interfere with the study medication application or study assessments.
Subject has, or has a history of, severe, progressive or uncontrolled autoimmune, metabolic, renal, hepatic, gastrointestinal, pulmonary, cardiovascular, genitourinary (i.e.,renal disease), hematological disease, neurologic or cerebral disorders, infectious disease or coagulation disorders that, in the opinion of the investigator, would interfere with the study assessments or put the subject at undue risk by study participation.
Subject currently has a history of, current, or suspected systemic or cutaneous malignancy and/or lymphoproliferative disease, other than a history of adequately treated, well healed and completely cleared non-melanoma skin cancers (e.g., basal or squamous cell carcinoma) treated successfully at least 1 year prior to study entry with no evidence of disease.
Subject currently has evidence of active or latent bacterial (including tuberculosis) or viral infections at the time of enrollment, or a history of incompletely treated or untreated tuberculosis. Subjects who have initiated therapy for latent tuberculosis for at least 2 weeks and agree to continue their therapy through completion may participate.
Subject has a history of serious local infection (e.g., cellulitis, abscess) or systemic infection, or history of treated infection (e.g., pneumonia, septicemia) within 3 months prior to the baseline visit. Subjects on an antibiotic for a nonserious, acute local infection must complete the course prior to enrollment into the study.
Subject has herpes zoster or cytomegalovirus (CMV) that resolved within 8 weeks prior to Visit 1.
Subject has a history of frequent outbreaks of oral Herpes Simplex Virus defined as more than 4 episodes per year.
Subjects previously treated with depigmenting agents.
Clinically significant laboratory abnormalities at screening that in the opinion of the investigator, would make the subject a poor candidate for the study.
Subject who has an absolute neutrophil count <1,000/mm3, or platelet count < 50,000/mL.
Subject unable to comply with the required washout periods
Subject who has participated in any investigational drug or device trial, regardless of indication in which administration of an investigational drug or device occurred within 30 days or 5 half-lives (whichever is longer) of screening (Visit 1). Note that investigational treatment for vitiligo (in any body area) requires a longer washout
Subjects with a clinically significant abnormal thyroid-stimulating hormone or free T4 at screening. Subjects under treatment with stable thyroid replacement who have a free T4 and TSH within the normal range may participate.
Subject has history of sensitivity to any of the ingredients in the study medication.
Subject has a history of, or current alcohol or drug abuse within 2 years of study enrollment.
Screening ECG findings of:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aclaris Investigator Site | Encinitas | California | 92024 | United States | ||
| Aclaris Investigator Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ATI-50002 0.46% Topical Solution | ATI-50002 0.46% topical solution, high dose active, twice-daily, 24 weeks ATI-50002 0.46% topical solution: Topical Solution administered twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ATI-50002 0.46% Topical Solution | ATI-50002 0.46% topical solution, high dose active, twice-daily, 24 weeks ATI-50002 0.46% topical solution: Topical Solution administered twice daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline to Week 24 | Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 24. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 24 Weeks |
|
The analysis included all treatment-emergent adverse events (TEAEs), defined as any recorded AE that occurred on or after the initiation of study medication and continue reporting until the end of the subject's last study visit (4-week post-treatment follow up visit).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ATI-50002 0.46% Topical Solution | ATI-50002 0.46% topical solution, high dose active, twice-daily, 24 weeks ATI-50002 0.46% topical solution: Topical Solution administered twice daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA version 22.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA version 22.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Gordon | Aclaris Therapeutics, Inc. | 484-540-6296 | Clintrials@aclaristx.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 8, 2019 | Aug 27, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 2, 2018 | Oct 5, 2020 | ICF_002.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline to 48 Weeks |
| Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 4 | Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 4. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Baseline to 4 Weeks |
| Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 8 | Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 8. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Baseline to 8 Weeks |
| Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 12 | Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 12. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Baseline to 12 Weeks |
| Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 16 | Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 4. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Baseline to 16 Weeks |
| Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Visit 2 Compared to Week 20 | Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 20. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Baseline to 20 Weeks |
| Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 32 | Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 4. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Baseline to 32 Weeks |
| Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 40 | Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 40. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Baseline to 40 Weeks |
| Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Post-treatment Week 52 | Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 52. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Baseline to 52 Weeks |
| Mean Change From Baseline in the Facial Assessment of the Vitiligo Area Scoring Index (F-VASI) Compared to Week 4 | The Facial Vitiligo Area Scoring Index (F-VASI) is an assessment of the subject's facial vitiligo modified from the Vitiligo Area Scoring Index for the face only at week 4. F-VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Baseline to 4 Weeks |
| Mean Change From Baseline in the Facial Assessment of the Vitiligo Area Scoring Index (F-VASI) Compared to Week 8 | The Facial Vitiligo Area Scoring Index (F-VASI) is an assessment of the subject's facial vitiligo modified from the Vitiligo Area Scoring Index for the face only at Week 8. F-VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Baseline to 8 Weeks |
| Mean Change From Baseline in the Facial Assessment of the Vitiligo Area Scoring Index (F-VASI) Compared to Week 12 | The Facial Vitiligo Area Scoring Index (F-VASI) is an assessment of the subject's facial vitiligo modified from the Vitiligo Area Scoring Index for the face only at week 12. F-VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Baseline to 12 Weeks |
| Mean Change From Baseline in the Facial Assessment of the Vitiligo Area Scoring Index (F-VASI) Compared to Week 16 | The Facial Vitiligo Area Scoring Index (F-VASI) is an assessment of the subject's facial vitiligo modified from the Vitiligo Area Scoring Index for the face only at week 16. F-VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Week 16 |
| Mean Change From Baseline in the Facial Assessment of the Vitiligo Area Scoring Index (F-VASI) Compared to Week 20 | The Facial Vitiligo Area Scoring Index (F-VASI) is an assessment of the subject's facial vitiligo modified from the Vitiligo Area Scoring Index for the face only at week 20. F-VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Baseline to 20 Weeks |
| Mean Change From Baseline in the Facial Assessment of the Vitiligo Area Scoring Index (F-VASI) Compared to Week 24 | The Facial Vitiligo Area Scoring Index (F-VASI) is an assessment of the subject's facial vitiligo modified from the Vitiligo Area Scoring Index for the face only at week 24. F-VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Baseline to 24 Weeks |
| Mean Change From Baseline in the Facial Assessment of the Vitiligo Area Scoring Index (F-VASI) Compared to Week 32 | The Facial Vitiligo Area Scoring Index (F-VASI) is an assessment of the subject's facial vitiligo modified from the Vitiligo Area Scoring Index for the face only at week 32. F-VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Baseline to 32 Weeks |
| Mean Change From Baseline in the Facial Assessment of the Vitiligo Area Scoring Index (F-VASI) Compared to Week 40 | The Facial Vitiligo Area Scoring Index (F-VASI) is an assessment of the subject's facial vitiligo modified from the Vitiligo Area Scoring Index for the face only at week 40. F-VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Baseline to 40 Weeks |
| Mean Change From Baseline in the Facial Assessment of the Vitiligo Area Scoring Index (F-VASI) Compared to Week 48 | The Facial Vitiligo Area Scoring Index (F-VASI) is an assessment of the subject's facial vitiligo modified from the Vitiligo Area Scoring Index for the face only at week 48. F-VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Baseline to 48 Weeks |
| Mean Change From Baseline in the Facial Assessment of the Vitiligo Area Scoring Index (F-VASI) Compared to Post-treatment Week 52 | The Facial Vitiligo Area Scoring Index (F-VASI) is an assessment of the subject's facial vitiligo modified from the Vitiligo Area Scoring Index for the face only at week 52. F-VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Baseline to 52 Weeks |
| Treatment Success Based on the Subject's Assessment of Vitiligo on the Vitiligo Noticeability Scale (VNS) at Week 4 | The Vitiligo Noticeability Scale (VNS) represents the subject's assessment of the noticeability of facial vitiligo during the study treatment period by means of answering the question, "Compared to before treatment, how noticeable is the vitiligo now?" Subject response options include, "1: More Noticeable", "2: As Noticeable", "3: Slightly Less Noticeable", "4: A Lot Less Noticeable", and "5: No Longer Noticeable". Treatment success will be defined as follows: VNS score of 1 or 2 = treatment not successful, VNS score of 3 = treatment partially successful, or VNS score of 4 or 5 = treatment successful. Higher scores represent better outcomes. | Baseline to 4 Weeks |
| Treatment Success Based on the Subject's Assessment of Vitiligo on the Vitiligo Noticeability Scale (VNS) at Week 8 | The Vitiligo Noticeability Scale (VNS) represents the subject's assessment of the noticeability of facial vitiligo during the study treatment period by means of answering the question, "Compared to before treatment, how noticeable is the vitiligo now?" Subject response options include, "1: More Noticeable", "2: As Noticeable", "3: Slightly Less Noticeable", "4: A Lot Less Noticeable", and "5: No Longer Noticeable". Treatment success will be defined as follows: VNS score of 1 or 2 = treatment not successful, VNS score of 3 = treatment partially successful, or VNS score of 4 or 5 = treatment successful. Higher scores represent better outcomes. | Baseline to 8 Weeks |
| Treatment Success Based on the Subject's Assessment of Vitiligo on the Vitiligo Noticeability Scale (VNS) at Week 12 | The Vitiligo Noticeability Scale (VNS) represents the subject's assessment of the noticeability of facial vitiligo during the study treatment period by means of answering the question, "Compared to before treatment, how noticeable is the vitiligo now?" Subject response options include, "1: More Noticeable", "2: As Noticeable", "3: Slightly Less Noticeable", "4: A Lot Less Noticeable", and "5: No Longer Noticeable". Treatment success will be defined as follows: VNS score of 1 or 2 = treatment not successful, VNS score of 3 = treatment partially successful, or VNS score of 4 or 5 = treatment successful. Higher scores represent better outcomes. | Baseline to 12 Weeks |
| Treatment Success Based on the Subject's Assessment of Vitiligo on the Vitiligo Noticeability Scale (VNS) at Week 16 | The Vitiligo Noticeability Scale (VNS) represents the subject's assessment of the noticeability of facial vitiligo during the study treatment period by means of answering the question, "Compared to before treatment, how noticeable is the vitiligo now?" Subject response options include, "1: More Noticeable", "2: As Noticeable", "3: Slightly Less Noticeable", "4: A Lot Less Noticeable", and "5: No Longer Noticeable". Treatment success will be defined as follows: VNS score of 1 or 2 = treatment not successful, VNS score of 3 = treatment partially successful, or VNS score of 4 or 5 = treatment successful. Higher scores represent better outcomes. | Baseline to 16 Weeks |
| Treatment Success Based on the Subject's Assessment of Vitiligo on the Vitiligo Noticeability Scale (VNS) at Week 20 | The Vitiligo Noticeability Scale (VNS) represents the subject's assessment of the noticeability of facial vitiligo during the study treatment period by means of answering the question, "Compared to before treatment, how noticeable is the vitiligo now?" Subject response options include, "1: More Noticeable", "2: As Noticeable", "3: Slightly Less Noticeable", "4: A Lot Less Noticeable", and "5: No Longer Noticeable". Treatment success will be defined as follows: VNS score of 1 or 2 = treatment not successful, VNS score of 3 = treatment partially successful, or VNS score of 4 or 5 = treatment successful. Higher scores represent better outcomes. | Baseline to 20 Weeks |
| Treatment Success Based on the Subject's Assessment of Vitiligo on the Vitiligo Noticeability Scale (VNS) at Week 24 | The Vitiligo Noticeability Scale (VNS) represents the subject's assessment of the noticeability of facial vitiligo during the study treatment period by means of answering the question, "Compared to before treatment, how noticeable is the vitiligo now?" Subject response options include, "1: More Noticeable", "2: As Noticeable", "3: Slightly Less Noticeable", "4: A Lot Less Noticeable", and "5: No Longer Noticeable". Treatment success will be defined as follows: VNS score of 1 or 2 = treatment not successful, VNS score of 3 = treatment partially successful, or VNS score of 4 or 5 = treatment successful. Higher scores represent better outcomes. | Baseline to 24 Weeks |
| Treatment Success Based on the Subject's Assessment of Vitiligo on the Vitiligo Noticeability Scale (VNS) at Week 32 | The Vitiligo Noticeability Scale (VNS) represents the subject's assessment of the noticeability of facial vitiligo during the study treatment period by means of answering the question, "Compared to before treatment, how noticeable is the vitiligo now?" Subject response options include, "1: More Noticeable", "2: As Noticeable", "3: Slightly Less Noticeable", "4: A Lot Less Noticeable", and "5: No Longer Noticeable". Treatment success will be defined as follows: VNS score of 1 or 2 = treatment not successful, VNS score of 3 = treatment partially successful, or VNS score of 4 or 5 = treatment successful. Higher scores represent better outcomes. | Baseline to 32 Weeks |
| Treatment Success Based on the Subject's Assessment of Vitiligo on the Vitiligo Noticeability Scale (VNS) at Week 40 | The Vitiligo Noticeability Scale (VNS) represents the subject's assessment of the noticeability of facial vitiligo during the study treatment period by means of answering the question, "Compared to before treatment, how noticeable is the vitiligo now?" Subject response options include, "1: More Noticeable", "2: As Noticeable", "3: Slightly Less Noticeable", "4: A Lot Less Noticeable", and "5: No Longer Noticeable". Treatment success will be defined as follows: VNS score of 1 or 2 = treatment not successful, VNS score of 3 = treatment partially successful, or VNS score of 4 or 5 = treatment successful. Higher scores represent better outcomes. | Baseline to 40 Weeks |
| Treatment Success Based on the Subject's Assessment of Vitiligo on the Vitiligo Noticeability Scale (VNS) at Week 48 | The Vitiligo Noticeability Scale (VNS) represents the subject's assessment of the noticeability of facial vitiligo during the study treatment period by means of answering the question, "Compared to before treatment, how noticeable is the vitiligo now?" Subject response options include, "1: More Noticeable", "2: As Noticeable", "3: Slightly Less Noticeable", "4: A Lot Less Noticeable", and "5: No Longer Noticeable". Treatment success will be defined as follows: VNS score of 1 or 2 = treatment not successful, VNS score of 3 = treatment partially successful, or VNS score of 4 or 5 = treatment successful. Higher scores represent better outcomes. | Baseline to 48 Weeks |
| Mean Change From Baseline in Total VASI at Week 24 | The Vitiligo Area Scoring Index (VASI) is an assessment of the subject's Vitiligo Area Scoring Index. VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Baseline to 24 Weeks |
| Mean Change From Baseline in Total VASI at Week 48 | The Vitiligo Area Scoring Index (VASI) is an assessment of the subject's Vitiligo Area Scoring Index. VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Baseline to 48 Weeks |
| Los Angeles |
| California |
| 90036 |
| United States |
| Aclaris Investigator Site | Worcester | Massachusetts | 01655 | United States |
| Aclaris Investigator Site | Dallas | Texas | 75390 | United States |
| Aclaris Investigator Site | Lynchburg | Virginia | 24501 | United States |
| Inclusion/Exclusion Enrollment Violator |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Fitzpatrick Skin Type | Count of Participants | Participants |
|
| Duration of Vitiligo Disease (years) (n) | Mean | Standard Deviation | years |
|
| Duration of Current Episode (years) (n) | Mean | Standard Deviation | years |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 48 | Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 48. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Subjects completing 24 weeks of treatment have the option to extend treatment for an additional 24 weeks. Subjects not wishing to continue treatment can withdraw consent. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 48 Weeks |
|
|
|
| Secondary | Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 4 | Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 4. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 4 Weeks |
|
|
|
| Secondary | Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 8 | Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 8. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 8 Weeks |
|
|
|
| Secondary | Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 12 | Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 12. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 Weeks |
|
|
|
| Secondary | Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 16 | Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 4. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 16 Weeks |
|
|
|
| Secondary | Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Visit 2 Compared to Week 20 | Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 20. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 20 Weeks |
|
|
|
| Secondary | Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 32 | Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 4. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Subjects completing 24 weeks of treatment have the option to extend treatment for an additional 24 weeks. Subjects not wishing to continue treatment can withdraw consent. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 32 Weeks |
|
|
|
| Secondary | Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 40 | Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 40. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Subjects completing 24 weeks of treatment have the option to extend treatment for an additional 24 weeks. Subjects not wishing to continue treatment can withdraw consent. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 40 Weeks |
|
|
|
| Secondary | Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Post-treatment Week 52 | Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 52. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Subjects completing 24 weeks of treatment have the option to extend treatment for an additional 24 weeks. Subjects not wishing to continue treatment can withdraw consent. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 52 Weeks |
|
|
|
| Secondary | Mean Change From Baseline in the Facial Assessment of the Vitiligo Area Scoring Index (F-VASI) Compared to Week 4 | The Facial Vitiligo Area Scoring Index (F-VASI) is an assessment of the subject's facial vitiligo modified from the Vitiligo Area Scoring Index for the face only at week 4. F-VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 4 Weeks |
|
|
|
| Secondary | Mean Change From Baseline in the Facial Assessment of the Vitiligo Area Scoring Index (F-VASI) Compared to Week 8 | The Facial Vitiligo Area Scoring Index (F-VASI) is an assessment of the subject's facial vitiligo modified from the Vitiligo Area Scoring Index for the face only at Week 8. F-VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 8 Weeks |
|
|
|
| Secondary | Mean Change From Baseline in the Facial Assessment of the Vitiligo Area Scoring Index (F-VASI) Compared to Week 12 | The Facial Vitiligo Area Scoring Index (F-VASI) is an assessment of the subject's facial vitiligo modified from the Vitiligo Area Scoring Index for the face only at week 12. F-VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 Weeks |
|
|
|
| Secondary | Mean Change From Baseline in the Facial Assessment of the Vitiligo Area Scoring Index (F-VASI) Compared to Week 16 | The Facial Vitiligo Area Scoring Index (F-VASI) is an assessment of the subject's facial vitiligo modified from the Vitiligo Area Scoring Index for the face only at week 16. F-VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Posted | Mean | Standard Deviation | score on a scale | Week 16 |
|
|
|
| Secondary | Mean Change From Baseline in the Facial Assessment of the Vitiligo Area Scoring Index (F-VASI) Compared to Week 20 | The Facial Vitiligo Area Scoring Index (F-VASI) is an assessment of the subject's facial vitiligo modified from the Vitiligo Area Scoring Index for the face only at week 20. F-VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 20 Weeks |
|
|
|
| Secondary | Mean Change From Baseline in the Facial Assessment of the Vitiligo Area Scoring Index (F-VASI) Compared to Week 24 | The Facial Vitiligo Area Scoring Index (F-VASI) is an assessment of the subject's facial vitiligo modified from the Vitiligo Area Scoring Index for the face only at week 24. F-VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 24 Weeks |
|
|
|
| Secondary | Mean Change From Baseline in the Facial Assessment of the Vitiligo Area Scoring Index (F-VASI) Compared to Week 32 | The Facial Vitiligo Area Scoring Index (F-VASI) is an assessment of the subject's facial vitiligo modified from the Vitiligo Area Scoring Index for the face only at week 32. F-VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Subjects completing 24 weeks of treatment have the option to extend treatment for an additional 24 weeks. Subjects not wishing to continue treatment can withdraw consent. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 32 Weeks |
|
|
|
| Secondary | Mean Change From Baseline in the Facial Assessment of the Vitiligo Area Scoring Index (F-VASI) Compared to Week 40 | The Facial Vitiligo Area Scoring Index (F-VASI) is an assessment of the subject's facial vitiligo modified from the Vitiligo Area Scoring Index for the face only at week 40. F-VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Subjects completing 24 weeks of treatment have the option to extend treatment for an additional 24 weeks. Subjects not wishing to continue treatment can withdraw consent. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 40 Weeks |
|
|
|
| Secondary | Mean Change From Baseline in the Facial Assessment of the Vitiligo Area Scoring Index (F-VASI) Compared to Week 48 | The Facial Vitiligo Area Scoring Index (F-VASI) is an assessment of the subject's facial vitiligo modified from the Vitiligo Area Scoring Index for the face only at week 48. F-VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Subjects completing 24 weeks of treatment have the option to extend treatment for an additional 24 weeks. Subjects not wishing to continue treatment can withdraw consent. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 48 Weeks |
|
|
|
| Secondary | Mean Change From Baseline in the Facial Assessment of the Vitiligo Area Scoring Index (F-VASI) Compared to Post-treatment Week 52 | The Facial Vitiligo Area Scoring Index (F-VASI) is an assessment of the subject's facial vitiligo modified from the Vitiligo Area Scoring Index for the face only at week 52. F-VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Subjects completing 24 weeks of treatment have the option to extend treatment for an additional 24 weeks. Subjects not wishing to continue treatment can withdraw consent. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 52 Weeks |
|
|
|
| Secondary | Treatment Success Based on the Subject's Assessment of Vitiligo on the Vitiligo Noticeability Scale (VNS) at Week 4 | The Vitiligo Noticeability Scale (VNS) represents the subject's assessment of the noticeability of facial vitiligo during the study treatment period by means of answering the question, "Compared to before treatment, how noticeable is the vitiligo now?" Subject response options include, "1: More Noticeable", "2: As Noticeable", "3: Slightly Less Noticeable", "4: A Lot Less Noticeable", and "5: No Longer Noticeable". Treatment success will be defined as follows: VNS score of 1 or 2 = treatment not successful, VNS score of 3 = treatment partially successful, or VNS score of 4 or 5 = treatment successful. Higher scores represent better outcomes. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 4 Weeks |
|
|
|
| Secondary | Treatment Success Based on the Subject's Assessment of Vitiligo on the Vitiligo Noticeability Scale (VNS) at Week 8 | The Vitiligo Noticeability Scale (VNS) represents the subject's assessment of the noticeability of facial vitiligo during the study treatment period by means of answering the question, "Compared to before treatment, how noticeable is the vitiligo now?" Subject response options include, "1: More Noticeable", "2: As Noticeable", "3: Slightly Less Noticeable", "4: A Lot Less Noticeable", and "5: No Longer Noticeable". Treatment success will be defined as follows: VNS score of 1 or 2 = treatment not successful, VNS score of 3 = treatment partially successful, or VNS score of 4 or 5 = treatment successful. Higher scores represent better outcomes. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 8 Weeks |
|
|
|
| Secondary | Treatment Success Based on the Subject's Assessment of Vitiligo on the Vitiligo Noticeability Scale (VNS) at Week 12 | The Vitiligo Noticeability Scale (VNS) represents the subject's assessment of the noticeability of facial vitiligo during the study treatment period by means of answering the question, "Compared to before treatment, how noticeable is the vitiligo now?" Subject response options include, "1: More Noticeable", "2: As Noticeable", "3: Slightly Less Noticeable", "4: A Lot Less Noticeable", and "5: No Longer Noticeable". Treatment success will be defined as follows: VNS score of 1 or 2 = treatment not successful, VNS score of 3 = treatment partially successful, or VNS score of 4 or 5 = treatment successful. Higher scores represent better outcomes. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 Weeks |
|
|
|
| Secondary | Treatment Success Based on the Subject's Assessment of Vitiligo on the Vitiligo Noticeability Scale (VNS) at Week 16 | The Vitiligo Noticeability Scale (VNS) represents the subject's assessment of the noticeability of facial vitiligo during the study treatment period by means of answering the question, "Compared to before treatment, how noticeable is the vitiligo now?" Subject response options include, "1: More Noticeable", "2: As Noticeable", "3: Slightly Less Noticeable", "4: A Lot Less Noticeable", and "5: No Longer Noticeable". Treatment success will be defined as follows: VNS score of 1 or 2 = treatment not successful, VNS score of 3 = treatment partially successful, or VNS score of 4 or 5 = treatment successful. Higher scores represent better outcomes. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 16 Weeks |
|
|
|
| Secondary | Treatment Success Based on the Subject's Assessment of Vitiligo on the Vitiligo Noticeability Scale (VNS) at Week 20 | The Vitiligo Noticeability Scale (VNS) represents the subject's assessment of the noticeability of facial vitiligo during the study treatment period by means of answering the question, "Compared to before treatment, how noticeable is the vitiligo now?" Subject response options include, "1: More Noticeable", "2: As Noticeable", "3: Slightly Less Noticeable", "4: A Lot Less Noticeable", and "5: No Longer Noticeable". Treatment success will be defined as follows: VNS score of 1 or 2 = treatment not successful, VNS score of 3 = treatment partially successful, or VNS score of 4 or 5 = treatment successful. Higher scores represent better outcomes. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 20 Weeks |
|
|
|
| Secondary | Treatment Success Based on the Subject's Assessment of Vitiligo on the Vitiligo Noticeability Scale (VNS) at Week 24 | The Vitiligo Noticeability Scale (VNS) represents the subject's assessment of the noticeability of facial vitiligo during the study treatment period by means of answering the question, "Compared to before treatment, how noticeable is the vitiligo now?" Subject response options include, "1: More Noticeable", "2: As Noticeable", "3: Slightly Less Noticeable", "4: A Lot Less Noticeable", and "5: No Longer Noticeable". Treatment success will be defined as follows: VNS score of 1 or 2 = treatment not successful, VNS score of 3 = treatment partially successful, or VNS score of 4 or 5 = treatment successful. Higher scores represent better outcomes. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 24 Weeks |
|
|
|
| Secondary | Treatment Success Based on the Subject's Assessment of Vitiligo on the Vitiligo Noticeability Scale (VNS) at Week 32 | The Vitiligo Noticeability Scale (VNS) represents the subject's assessment of the noticeability of facial vitiligo during the study treatment period by means of answering the question, "Compared to before treatment, how noticeable is the vitiligo now?" Subject response options include, "1: More Noticeable", "2: As Noticeable", "3: Slightly Less Noticeable", "4: A Lot Less Noticeable", and "5: No Longer Noticeable". Treatment success will be defined as follows: VNS score of 1 or 2 = treatment not successful, VNS score of 3 = treatment partially successful, or VNS score of 4 or 5 = treatment successful. Higher scores represent better outcomes. | Subjects completing 24 weeks of treatment have the option to extend treatment for an additional 24 weeks. Subjects not wishing to continue treatment can withdraw consent. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 32 Weeks |
|
|
|
| Secondary | Treatment Success Based on the Subject's Assessment of Vitiligo on the Vitiligo Noticeability Scale (VNS) at Week 40 | The Vitiligo Noticeability Scale (VNS) represents the subject's assessment of the noticeability of facial vitiligo during the study treatment period by means of answering the question, "Compared to before treatment, how noticeable is the vitiligo now?" Subject response options include, "1: More Noticeable", "2: As Noticeable", "3: Slightly Less Noticeable", "4: A Lot Less Noticeable", and "5: No Longer Noticeable". Treatment success will be defined as follows: VNS score of 1 or 2 = treatment not successful, VNS score of 3 = treatment partially successful, or VNS score of 4 or 5 = treatment successful. Higher scores represent better outcomes. | Subjects completing 24 weeks of treatment have the option to extend treatment for an additional 24 weeks. Subjects not wishing to continue treatment can withdraw consent. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 40 Weeks |
|
|
|
| Secondary | Treatment Success Based on the Subject's Assessment of Vitiligo on the Vitiligo Noticeability Scale (VNS) at Week 48 | The Vitiligo Noticeability Scale (VNS) represents the subject's assessment of the noticeability of facial vitiligo during the study treatment period by means of answering the question, "Compared to before treatment, how noticeable is the vitiligo now?" Subject response options include, "1: More Noticeable", "2: As Noticeable", "3: Slightly Less Noticeable", "4: A Lot Less Noticeable", and "5: No Longer Noticeable". Treatment success will be defined as follows: VNS score of 1 or 2 = treatment not successful, VNS score of 3 = treatment partially successful, or VNS score of 4 or 5 = treatment successful. Higher scores represent better outcomes. | Subjects completing 24 weeks of treatment have the option to extend treatment for an additional 24 weeks. Subjects not wishing to continue treatment can withdraw consent. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 48 Weeks |
|
|
|
| Secondary | Mean Change From Baseline in Total VASI at Week 24 | The Vitiligo Area Scoring Index (VASI) is an assessment of the subject's Vitiligo Area Scoring Index. VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 24 Weeks |
|
|
|
| Secondary | Mean Change From Baseline in Total VASI at Week 48 | The Vitiligo Area Scoring Index (VASI) is an assessment of the subject's Vitiligo Area Scoring Index. VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 48 Weeks |
|
|
|
| 0 |
| 34 |
| 2 |
| 34 |
| 23 |
| 34 |
| Alcoholic pancreatitis | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Application site acne | General disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Application site discolouration | General disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Application site dryness | General disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Application site pain | General disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Application site rash | General disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA version 22.0 | Systematic Assessment |
|
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA version 22.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA version 22.0 | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA version 22.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA version 22.0 | Systematic Assessment |
|
| Blood pressure systolic increased | Investigations | MedDRA version 22.0 | Systematic Assessment |
|
| Blood thyroid stimulating hormone decreased | Investigations | MedDRA version 22.0 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA version 22.0 | Systematic Assessment |
|
| Blood urine present | Investigations | MedDRA version 22.0 | Systematic Assessment |
|
| Eosinophil count increased | Investigations | MedDRA version 22.0 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA version 22.0 | Systematic Assessment |
|
| Low density lipoprotein increased | Investigations | MedDRA version 22.0 | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA version 22.0 | Systematic Assessment |
|
| Red blood cell count increased | Investigations | MedDRA version 22.0 | Systematic Assessment |
|
| Specific gravity urine decreased | Investigations | MedDRA version 22.0 | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA version 22.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Alcohol abuse | Psychiatric disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Pruritus allergic | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Excessive exercise | Social circumstances | MedDRA version 22.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA version 22.0 | Systematic Assessment |
|
Not provided
Not provided