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The study evaluated the safety, tolerability, and efficacy of ACCU-D1 when applied twice daily for 12 weeks in adult participants with moderate to severe acne rosacea. Two-third of the participants received ACCU-D1 while one-third of the participants received vehicle control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACU-D1 Ointment | Experimental | Twice-daily application of ACU-D1 ointment to the face for 12 weeks. |
|
| ACU-D1 Ointment Vehicle | Placebo Comparator | Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACCU-D1 | Drug | ACCU-D1 |
| |
| Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Lesion Count at Week 12 | Total lesion count was the sum of counts of the following lesion types (face only): Papule - raised inflammatory lesions, <0.5 cm in diameter with no visible purulent material; Pustule - raised inflammatory lesions, <0.5 cm in diameter with visible purulent material; Nodule - any circumscribed, inflammatory mass ≥0.5 cm in diameter. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Investigator's Global Assessment (IGA) Score at Weeks 2, 4, 8, and 12 | The IGA score is an ordered categorical value ranging from 0 (clear) to 4 (severe). A lower score indicated improvement in the condition. Score 0 (clear): no papules or pustules, no nodules, none or barely perceptible erythema Score 1 (near clear): very few (≤3) papules and/or pustules, no nodules, very mild erythema Score 2 (mild): few papules and pustules present, no nodules, mild erythema Score 3 (moderate): several papules and pustules are the predominant features, ≤2 nodules may be present, moderate erythema Score 4 (severe): numerous papules and pustules, multiple nodules may be present, severe erythema |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Week 12 | Erythema score was evaluated by the investigator on a 0 to 3 scale with a lower score indicating lesser severity. Score 0 (clear): no erythema present Score 1 (mild): slight erythema Score 2 (moderate): definite erythema Score 3 (severe): marked, fiery erythema | Week 12 |
Inclusion Criteria:
Exclusion Criteria:
Participant is pregnant, nursing, or planning to become pregnant during the duration of the study
Participant has used systemic glucocorticosteroids within 42 days prior to Visit 1 (inhaled and ocular glucocorticosteroids are permitted)
Participant has used systemic antibiotics within 28 days prior to Visit 1
Participant has used any topical glucocorticosteroids on the face within 28 days prior to Visit 1
Participant has used any prescription or over-the-counter product for the treatment of acne or rosacea within 14 days prior to Visit 1
Participant is currently using any therapy that, in the investigator's opinion, is a photosensitizer (for example, phenothiazines, amiodarone, quinine, thiazides, sulphonamides, quinolones, etc.)
Participant currently has any skin disease (for example, psoriasis, atopic dermatitis, eczema), or condition (for example, actinic keratosis, photo-damage, sunburn, excessive hair, open wounds) that, in the investigator's opinion, might impair evaluation of rosacea or which exposes the subject to an unacceptable risk by study participation
Participant currently has, on the face, or has had on the face, any of the following within the specified period prior to Visit 1 that, in the investigator's opinion, might impair evaluation of rosacea or which exposes the subject to an unacceptable risk by study participation:
Participant has facial hair, that in the investigator's opinion, might impair evaluation of rosacea or proper study medication application
Participant has a history of sensitivity to any of the ingredients in the study medications
Participant has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to Visit 1
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DS Research | Louisville | Kentucky | 40421 | United States | ||
| DermResearch |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34076401 | Derived | Jackson JM, Coulon R, Arbiser JL. Evaluation of a First-in-Class Proteasome Inhibitor in Patients With Moderate to Severe Rosacea. J Drugs Dermatol. 2021 Jun 1;20(6):660-664. doi: 10.36849/JDD.2021.5925. |
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Eligible participants will be assigned in a random manner to 1 of the 2 study medications in a 2:1 ratio (ACU-D1 ointment: ACU-D1 ointment vehicle).
The study was conducted at two sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | ACU-D1 Ointment | Twice-daily application of ACU-D1 ointment to the face for 12 weeks. |
| FG001 | ACU-D1 Ointment Vehicle | Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The modified intention-to-treat (MITT) population included all randomized participants who were dispensed study medication and provided any post-baseline efficacy data.
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| ID | Title | Description |
|---|---|---|
| BG000 | ACU-D1 Ointment | Twice-daily application of ACU-D1 ointment to the face for 12 weeks. |
| BG001 | ACU-D1 Ointment Vehicle | Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks. |
| 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 | Change From Baseline in Total Lesion Count at Week 12 | Total lesion count was the sum of counts of the following lesion types (face only): Papule - raised inflammatory lesions, <0.5 cm in diameter with no visible purulent material; Pustule - raised inflammatory lesions, <0.5 cm in diameter with visible purulent material; Nodule - any circumscribed, inflammatory mass ≥0.5 cm in diameter. | Number of participants included participants in the MITT population with available data at Week 12. | Posted | Least Squares Mean | Standard Error | number of lesions | Baseline, Week 12 |
|
Baseline up to Week 14
Safety population
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ACU-D1 Ointment | Twice-daily application of ACU-D1 ointment to the face for 12 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Science Officer | Accuitis, Inc. | 678-812-1492 | info@accuitis.com |
| Type | Description | Creation Date | Issued Date | Release Date | Posted Date |
|---|---|---|---|---|---|
| Correction Confirmed by FDA | The responsible party has corrected the violation. | Jun 6, 2022 | May 26, 2022 | Aug 17, 2021 | Jun 7, 2022 |
| Violation Identified by FDA | Failure to Submit. The entry for this clinical trial was not complete at the time of submission, as required by law. This may or may not have any bearing on the accuracy of the information in the entry. | Jul 28, 2021 | Jul 26, 2021 | Apr 12, 2018 | Jul 29, 2021 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 5, 2017 | Aug 13, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 11, 2018 | Aug 13, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Drug |
Placebo Comparator |
|
| Baseline; Weeks 2, 4, 8, and 12 |
| Percentage of Participants Who Were Treatment Responders at Week 12 | Treatment responders were defined as participants who have either (1) 2 ordinal or more reductions in the IGA score from baseline or (2) an IGA score of 0 or 1. The IGA score is an ordered categorical value ranging from 0 (clear) to 4 (severe). A lower score indicated improvement in the condition. Score 0 (clear): no papules or pustules, no nodules, none or barely perceptible erythema Score 1 (near clear): very few (≤3) papules and/or pustules, no nodules, very mild erythema Score 2 (mild): few papules and pustules present, no nodules, mild erythema Score 3 (moderate): several papules and pustules are the predominant features, ≤2 nodules may be present, moderate erythema Score 4 (severe): numerous papules and pustules, multiple nodules may be present, severe erythema | Baseline, Week 12 |
| Change From Baseline in Papule Lesions at Weeks 2, 4, 8, and 12 | Papule - raised inflammatory lesions, <0.5 cm in diameter with no visible purulent material | Baseline; Weeks 2, 4, 8, and 12 |
| Change From Baseline in Pustule Lesions at Weeks 2, 4, 8, and 12 | Pustule - raised inflammatory lesions, <0.5 cm in diameter with visible purulent material | Baseline; Weeks 2, 4, 8, and 12 |
| Change From Baseline in Nodule Lesions at Weeks 2, 4, 8, and 12 | Nodule - any circumscribed, inflammatory mass ≥0.5 cm in diameter | Baseline; Weeks 2, 4, 8, and 12 |
| Change From Baseline in Papules + Pustules Lesions at Weeks 2, 4, 8, and 12 | Papules + pustules lesions were the sum of counts of papule (raised inflammatory lesions, <0.5 cm in diameter with no visible purulent material) and pustule (raised inflammatory lesions, <0.5 cm in diameter with visible purulent material) lesions. | Baseline; Weeks 2, 4, 8, and 12 |
| Number of Participants With Adverse Events | Number of participants reporting any adverse event including local tolerability of signs and symptoms of irritation, clinical laboratory safety tests, and vital signs. | Baseline to Week 14 |
| Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Erythema score was evaluated by the investigator on a 0 to 3 scale with a lower score indicating lesser severity. Score 0 (clear): no erythema present Score 1 (mild): slight erythema Score 2 (moderate): definite erythema Score 3 (severe): marked, fiery erythema | Day 1 (Post-application) and Weeks 2, 4, 8, and 14 |
| Austin |
| Texas |
| 78759 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Total lesion count | Total lesion count was the sum of counts of the following lesion types (face only): Papule - raised inflammatory lesions, < 0.5 cm in diameter with no visible purulent material; Pustule - raised inflammatory lesions, < 0.5 cm in diameter with visible purulent material; Nodule - any circumscribed, inflammatory mass ≥ 0.5 cm in diameter. | Mean | Standard Deviation | number of lesions |
|
| Erythema score based on local tolerability as assessed by the investigator | Erythema score at baseline (pre-application) was evaluated by the investigator on a 0 to 3 scale with a lower score indicating lesser severity. Score 0 (clear): no erythema present; Score 1 (mild): slight erythema; Score 2 (moderate): definite erythema; Score 3 (severe): marked, fiery erythema. The assessment was based on the safety population which included all randomized participants who received at least 1 dose of study medication. | Count of Participants | Participants |
|
Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks. |
|
|
|
| Secondary | Percent Change From Baseline in Investigator's Global Assessment (IGA) Score at Weeks 2, 4, 8, and 12 | The IGA score is an ordered categorical value ranging from 0 (clear) to 4 (severe). A lower score indicated improvement in the condition. Score 0 (clear): no papules or pustules, no nodules, none or barely perceptible erythema Score 1 (near clear): very few (≤3) papules and/or pustules, no nodules, very mild erythema Score 2 (mild): few papules and pustules present, no nodules, mild erythema Score 3 (moderate): several papules and pustules are the predominant features, ≤2 nodules may be present, moderate erythema Score 4 (severe): numerous papules and pustules, multiple nodules may be present, severe erythema | MITT population. Number of participants analyzed included participants with available data at specific timepoint. | Posted | Mean | Standard Deviation | percent change | Baseline; Weeks 2, 4, 8, and 12 |
|
|
|
|
| Secondary | Percentage of Participants Who Were Treatment Responders at Week 12 | Treatment responders were defined as participants who have either (1) 2 ordinal or more reductions in the IGA score from baseline or (2) an IGA score of 0 or 1. The IGA score is an ordered categorical value ranging from 0 (clear) to 4 (severe). A lower score indicated improvement in the condition. Score 0 (clear): no papules or pustules, no nodules, none or barely perceptible erythema Score 1 (near clear): very few (≤3) papules and/or pustules, no nodules, very mild erythema Score 2 (mild): few papules and pustules present, no nodules, mild erythema Score 3 (moderate): several papules and pustules are the predominant features, ≤2 nodules may be present, moderate erythema Score 4 (severe): numerous papules and pustules, multiple nodules may be present, severe erythema | MITT population. Number of participants analyzed included participants with available IGA score at Week 12. | Posted | Number | percentage of participants | Baseline, Week 12 |
|
|
|
|
| Secondary | Change From Baseline in Papule Lesions at Weeks 2, 4, 8, and 12 | Papule - raised inflammatory lesions, <0.5 cm in diameter with no visible purulent material | MITT population. Number of participants analyzed included participants with available data at specified visits. | Posted | Least Squares Mean | Standard Error | number of lesions | Baseline; Weeks 2, 4, 8, and 12 |
|
|
|
|
| Secondary | Change From Baseline in Pustule Lesions at Weeks 2, 4, 8, and 12 | Pustule - raised inflammatory lesions, <0.5 cm in diameter with visible purulent material | MITT population. Number of participants analyzed included participants with available data at specified visits. | Posted | Least Squares Mean | Standard Error | number of lesions | Baseline; Weeks 2, 4, 8, and 12 |
|
|
|
|
| Secondary | Change From Baseline in Nodule Lesions at Weeks 2, 4, 8, and 12 | Nodule - any circumscribed, inflammatory mass ≥0.5 cm in diameter | MITT population. Number of participants analyzed included participants with available data at specified visits. | Posted | Least Squares Mean | Standard Error | number of lesions | Baseline; Weeks 2, 4, 8, and 12 |
|
|
|
|
| Secondary | Change From Baseline in Papules + Pustules Lesions at Weeks 2, 4, 8, and 12 | Papules + pustules lesions were the sum of counts of papule (raised inflammatory lesions, <0.5 cm in diameter with no visible purulent material) and pustule (raised inflammatory lesions, <0.5 cm in diameter with visible purulent material) lesions. | MITT population. Number of participants analyzed included participants with available data at specified visits. | Posted | Least Squares Mean | Standard Error | number of lesions | Baseline; Weeks 2, 4, 8, and 12 |
|
|
|
|
| Secondary | Number of Participants With Adverse Events | Number of participants reporting any adverse event including local tolerability of signs and symptoms of irritation, clinical laboratory safety tests, and vital signs. | Safety population included all randomized participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Baseline to Week 14 |
|
|
|
| Other Pre-specified | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Week 12 | Erythema score was evaluated by the investigator on a 0 to 3 scale with a lower score indicating lesser severity. Score 0 (clear): no erythema present Score 1 (mild): slight erythema Score 2 (moderate): definite erythema Score 3 (severe): marked, fiery erythema | Safety population included all randomized participants who received at least 1 dose of study medication. Number of participants analyzed included participants with available data at specified timepoints. | Posted | Count of Participants | Participants | Week 12 |
|
|
|
| Other Pre-specified | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 | Erythema score was evaluated by the investigator on a 0 to 3 scale with a lower score indicating lesser severity. Score 0 (clear): no erythema present Score 1 (mild): slight erythema Score 2 (moderate): definite erythema Score 3 (severe): marked, fiery erythema | Safety population. Number of participants analyzed included participants with available data at specified timepoints. | Posted | Count of Participants | Participants | Day 1 (Post-application) and Weeks 2, 4, 8, and 14 |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 11 |
| 27 |
| EG001 | ACU-D1 Ointment Vehicle | Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks. | 0 | 13 | 0 | 13 | 4 | 13 |
| Administration site dryness | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Administration site warmth | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Application site perspiration | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
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| Week 4 |
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| 0.1653 |
| Superiority |
| Percent change from baseline at Week 8 | Van Elteren test | 0.8437 | Superiority |
| Percent change from baseline at Week 12 | Van Elteren test | 0.4644 | Superiority |
| Week 4 |
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| t-test, 2 sided |
| 0.399 |
| Difference of LS Mean |
| -1.5 |
| Standard Error of the Mean |
| 1.74 |
| 2-Sided |
| 95 |
| -5.014 |
| 2.045 |
| Superiority |
| Change from baseline at Week 8 | t-test, 2 sided | 0.290 | Difference of LS Mean | 2.2 | Standard Error of the Mean | 2.07 | 2-Sided | 95 | -1.965 | 6.407 | Superiority |
| Change from baseline at Week 12 | t-test, 2 sided | 0.343 | Difference of LS Mean | 1.8 | Standard Error of the Mean | 1.83 | 2-Sided | 95 | -1.953 | 5.469 | Superiority |
| Week 4 |
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| t-test, 2 sided |
| 0.291 |
| Difference of LS Mean |
| 0.4 |
| Standard Error of the Mean |
| 0.36 |
| 2-Sided |
| 95 |
| -0.342 |
| 1.109 |
| Superiority |
| Change from baseline at Week 8 | t-test, 2 sided | 0.734 | Difference of LS Mean | 0.2 | Standard Error of the Mean | 0.45 | 2-Sided | 95 | -0.763 | 1.073 | Superiority |
| Change from baseline in pustule lesions at Week 12 | t-test, 2 sided | 0.952 | Difference of LS Mean | 0.0 | Standard Error of the Mean | 0.57 | 2-Sided | 95 | -1.128 | 1.197 | Superiority |
| Week 4 |
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| t-test, 2 sided |
| 0.942 |
| Difference of LS Mean |
| 0.0 |
| Standard Error of the Mean |
| 0.07 |
| 2-Sided |
| 95 |
| -0.141 |
| 0.152 |
| Superiority |
| Change from baseline in nodule lesions at Week 8 | t-test, 2 sided | 0.284 | Difference of LS Mean | 0.1 | Standard Error of the Mean | 0.07 | 2-Sided | 95 | -0.067 | 0.226 | Superiority |
| Change from baseline at Week 12 | t-test, 2 sided | 0.542 | Difference of LS Mean | 0.0 | Standard Error of the Mean | 0.08 | 2-Sided | 95 | -0.198 | 0.105 | Superiority |
| Week 4 |
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| t-test, 2 sided |
| 0.591 |
| Difference of LS Mean |
| -1.0 |
| Standard Error of the Mean |
| 1.90 |
| 2-Sided |
| 95 |
| -4.882 |
| 2.822 |
| Superiority |
| Change from baseline at Week 8 | t-test, 2 sided | 0.254 | Difference of LS Mean | 2.5 | Standard Error of the Mean | 2.12 | 2-Sided | 95 | -1.840 | 6.758 | Superiority |
| Change from baseline at Week 12 | t-test, 2 sided | 0.356 | Difference of LS Mean | 1.8 | Standard Error of the Mean | 1.95 | 2-Sided | 95 | -2.131 | 5.779 | Superiority |
| Score 2 (moderate) |
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| Score 3 (severe) |
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| Score 1 (mild) |
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| Score 2 (moderate) |
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| Score 3 (severe) |
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| Week 2 |
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| Week 4 |
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| Week 8 |
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| Week 14 |
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