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Exploratory, multi-centric, randomized, vehicle-controlled, investigator-blind, parallel group study, involved participants with chronic lesions of Atopic Dermatitis (AD) to evaluate the local and systemic safety of CD5024 0.3% cream over a 6-week treatment period compared to its vehicle.
Study application was performed once daily, 7 days a week for 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD5024 0.3% cream | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD5024 0.3% cream | Drug | Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 milligrams per centimeter square (mg/cm^2) once daily for 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Eczema Area and Severity Index (EASI) Score at Day 43 | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum), with the higher scores indicated the worse severity of AD. All missing values were imputed by Last Observation Carried Forward (LOCF). | Baseline, Day 43 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in EASI at Each Visit | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores indicated the worse severity of AD. All missing values were imputed by LOCF. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Investigational Site (#8581) | Mississauga | Ontario | L5H 1G9 | Canada | ||
| Galderma Investigational Site (# 8338) |
A total of 101 participants were screened in the study. Out of which, 63 participants were randomized in a ratio of 1:1 to receive CD5024 0.3 percent (%) cream or its vehicle. Screen failures were mainly due to exclusion criteria met.
The study was conducted at 5 centers in Canada between 01 November 2016 and 26 June 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | CD5024 0.3% Cream | Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 milligrams per centimeters square (mg/cm^2) once daily for 6 weeks. |
| FG001 | Placebo | Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm^2 once daily for 6 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Intent-to-treat (ITT) efficacy analysis set was defined as any participants who are randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | CD5024 0.3% Cream | Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm^2 once daily for 6 weeks. |
| BG001 | Placebo |
| 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 Eczema Area and Severity Index (EASI) Score at Day 43 | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum), with the higher scores indicated the worse severity of AD. All missing values were imputed by Last Observation Carried Forward (LOCF). | The Intent-to-treat (ITT) efficacy analysis set was defined as any participant who were randomized. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Day 43 |
|
Up to Week 9
The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.
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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 | CD5024 0.3% Cream | Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm^2 once daily for 6 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Galderma | 817 961 5000 | 1 | Clinical.Studies@galderma.com |
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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 | Jan 13, 2017 | Jun 27, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 21, 2017 | Jun 24, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| D007559 | Ivermectin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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|
| Placebo | Drug | Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm^2 once daily for 6 weeks. |
|
| Baseline, Days 8,15, 22, 29, 36 and 43 |
| Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear) | IGA scale consisted of 5 grades (0-4) among which 0 = Clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting), 1 = Almost clear (Trace, faint pink erythema with almost no induration/papulation and no oozing/crusting), 2 = Mild (Faint pink erythema with mild induration/papulation and no oozing/crusting), 3 = Moderate (Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting.), 4 = Severe (Deep/bright red erythema with severe induration/papulation with oozing/crusting). Success rate was defined as percentage of participants who achieved an IGA score of 1 (almost clear) or 0 (Clear) at specified visits. All missing values were imputed by LOCF. | Days 8, 15, 22, 29, 36 and 43 |
| Percent Change From Baseline in Total Sum Score (TSS) at Each Visit | The TSS was the sum of individual clinical severity scores for 5 signs of AD (erythema, induration/papulation, oozing/crusting, excoriation and lichenification). The severity of each sign was evaluated by using a 4-graded scale (0: none; 1: mild; 2: moderate; 3: severe). The total score ranges from 0 to 15, where higher score indicated worse severity of AD. All missing values were imputed by LOCF. | Baseline, Days 8, 15, 22, 29, 36 and 43 |
| Percent Change From Baseline in Modified Objective Scoring Atopic Dermatitis (SCORAD) at Each Visit | SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with visual analog scale (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. Higher scores indicated worse outcome. All missing values were imputed by LOCF. | Baseline, Days 8, 15, 22, 29, 36 and 43 |
| Change From Baseline in Pruritus Numerical Rating Scale (NRS) at Each Visit | Pruritus NRS was a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 = 'no itch' and 10 = 'worst itch imaginable', where higher score indicated very severe itch. All missing values were imputed by LOCF. | Baseline, Weeks 1, 2, 3, 4, 5 and 6 |
| Change From Baseline in Pruritus Verbal Rating Scale (VRS) Score at Day 43 | Participants were asked for a response that best described their pruritus intensity in last 24 hours, to rate their itch using a list of adjectives describing different levels of symptom intensity rated on a scale of 0 to 3 that is (i.e.) 0 = No itch, 1 = low, 2 = Moderate and 3 = Severe, where higher score indicated very severe itch. All missing values were imputed by LOCF. | Baseline, Day 43 |
| Richmond Hill |
| Ontario |
| L4B 1A5 |
| Canada |
| Galderma Investigational Site (#8587) | Richmond Hill | Ontario | L4C 9M7 | Canada |
| Galderma Investigational Site (# 8060) | Windsor | Ontario | N8W 5L7 | Canada |
| Galderma Investigational Site (#8089) | Montreal | Quebec | H2K 4L5 | Canada |
| Other |
|
Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm^2 once daily for 6 weeks.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Eczema Area and Severity Index (EASI) Score | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores indicated the worse severity of AD. | Mean | Standard Deviation | score on a scale |
|
| OG001 | Placebo | Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm^2 once daily for 6 weeks. |
|
|
|
| Secondary | Percent Change From Baseline in EASI at Each Visit | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores indicated the worse severity of AD. All missing values were imputed by LOCF. | The ITT efficacy analysis set was defined as any participant who were randomized. | Posted | Mean | Standard Deviation | percent change | Baseline, Days 8,15, 22, 29, 36 and 43 |
|
|
|
| Secondary | Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear) | IGA scale consisted of 5 grades (0-4) among which 0 = Clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting), 1 = Almost clear (Trace, faint pink erythema with almost no induration/papulation and no oozing/crusting), 2 = Mild (Faint pink erythema with mild induration/papulation and no oozing/crusting), 3 = Moderate (Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting.), 4 = Severe (Deep/bright red erythema with severe induration/papulation with oozing/crusting). Success rate was defined as percentage of participants who achieved an IGA score of 1 (almost clear) or 0 (Clear) at specified visits. All missing values were imputed by LOCF. | The ITT efficacy analysis set was defined as any participant who were randomized. | Posted | Number | percentage of participants | Days 8, 15, 22, 29, 36 and 43 |
|
|
|
| Secondary | Percent Change From Baseline in Total Sum Score (TSS) at Each Visit | The TSS was the sum of individual clinical severity scores for 5 signs of AD (erythema, induration/papulation, oozing/crusting, excoriation and lichenification). The severity of each sign was evaluated by using a 4-graded scale (0: none; 1: mild; 2: moderate; 3: severe). The total score ranges from 0 to 15, where higher score indicated worse severity of AD. All missing values were imputed by LOCF. | The ITT efficacy analysis set was defined as any participant who were randomized. | Posted | Least Squares Mean | Standard Error | percent change | Baseline, Days 8, 15, 22, 29, 36 and 43 |
|
|
|
| Secondary | Percent Change From Baseline in Modified Objective Scoring Atopic Dermatitis (SCORAD) at Each Visit | SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with visual analog scale (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. Higher scores indicated worse outcome. All missing values were imputed by LOCF. | The ITT efficacy analysis set was defined as any participant who were randomized. | Posted | Least Squares Mean | Standard Error | percent change | Baseline, Days 8, 15, 22, 29, 36 and 43 |
|
|
|
| Secondary | Change From Baseline in Pruritus Numerical Rating Scale (NRS) at Each Visit | Pruritus NRS was a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 = 'no itch' and 10 = 'worst itch imaginable', where higher score indicated very severe itch. All missing values were imputed by LOCF. | The ITT efficacy analysis set was defined as any participant who were randomized. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 1, 2, 3, 4, 5 and 6 |
|
|
|
| Secondary | Change From Baseline in Pruritus Verbal Rating Scale (VRS) Score at Day 43 | Participants were asked for a response that best described their pruritus intensity in last 24 hours, to rate their itch using a list of adjectives describing different levels of symptom intensity rated on a scale of 0 to 3 that is (i.e.) 0 = No itch, 1 = low, 2 = Moderate and 3 = Severe, where higher score indicated very severe itch. All missing values were imputed by LOCF. | The ITT efficacy analysis set was defined as any participant who were randomized. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 43 |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 16 |
| 32 |
| EG001 | Placebo | Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm^2 once daily for 6 weeks. | 0 | 31 | 0 | 31 | 21 | 31 |
| Upper respiratory tract infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Tinea cruris | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Burns first degree | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Post procedural inflammation | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Face injury | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Eyelid pain | Eye disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v19.0 | Non-systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Vessel puncture site bruise | General disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA v19.0 | Non-systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA v19.0 | Non-systematic Assessment |
|
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Day 22 |
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| Day 29 |
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| Day 36 |
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| Day 43 |
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| Day 22 |
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| Day 29 |
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| Day 36 |
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| Day 43 |
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| Day 22 |
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| Day 29 |
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| Day 36 |
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| Day 43 |
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| Day 22 |
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| Day 29 |
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| Day 36 |
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| Day 43 |
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| Week 3 |
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| Week 4 |
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| Week 5 |
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| Week 6 |
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