A Phase 2 interventional study of CD5024 0.3% cream and Placebo in Atopic Dermatitis, sponsored by Galderma R&D. Completed at 5 sites in Canada. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-05-01.
Sponsored by Galderma R&D · Phase 2, Interventional, and Other
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.
Exclusion Criteria:
Drug: CD5024 0.3% cream
Drug: Placebo
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.
Also known as: Ivermectin
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.
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).
Time frame: Baseline, Day 43
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Day 43
The study was conducted at 5 centers in Canada between 01 November 2016 and 26 June 2017.
| Milestone | CD5024 0.3% Cream | Placebo |
|---|---|---|
| Started | 32 | 31 |
| Completed | 30 | 24 |
| Not completed | 2 | 7 |
| Withdrew: Lack of efficacy | 1 | 4 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Other | 1 | 2 |
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).
| score on a scale | CD5024 0.3% Cream | Placebo |
|---|---|---|
| Change From Baseline in Eczema Area and Severity Index (EASI) Score at Day 43 | -2.64 ± 0.41 | -2.36 ± 0.44 |
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.
| percent change | CD5024 0.3% Cream | Placebo |
|---|---|---|
| Day 8 | -8.7 ± 19.1 | -5.5 ± 39.6 |
| Day 15 | -21.0 ± 37.5 | -10.7 ± 43.7 |
| Day 22 | -29.1 ± 40.7 | -26.7 ± 35.8 |
| Day 29 | -34.5 ± 59.9 | -21.0 ± 41.7 |
| Day 36 | -43.1 ± 35.3 | -28.8 ± 44.7 |
| Day 43 | -46.4 ± 38.8 | -24.6 ± 62.7 |
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.
| percentage of participants | CD5024 0.3% Cream | Placebo |
|---|---|---|
| Day 8 | 0 | 3.23 |
| Day 15 | 3.13 | 6.45 |
| Day 22 | 9.38 | 9.68 |
| Day 29 | 15.6 | 6.45 |
| Day 36 | 21.9 | 16.1 |
| Day 43 | 37.5 | 9.68 |
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.
| percent change | CD5024 0.3% Cream | Placebo |
|---|---|---|
| Day 8 | -15.35 ± 4.51 | -17.30 ± 4.75 |
| Day 15 | -27.94 ± 5.76 | -20.82 ± 6.07 |
| Day 22 | -29.38 ± 6.23 | -33.57 ± 6.57 |
| Day 29 | -37.23 ± 6.64 | -34.44 ± 6.99 |
| Day 36 | -45.01 ± 6.75 | 42.24 ± 7.11 |
| Day 43 | -47.63 ± 7.30 | -45.00 ± 7.69 |
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.
| percent change | CD5024 0.3% Cream | Placebo |
|---|---|---|
| Day 8 | -16.28 ± 4.29 | -16.00 ± 4.52 |
| Day 15 | -30.76 ± 5.51 | -20.49 ± 5.81 |
| Day 22 | -32.02 ± 5.84 | -30.73 ± 6.16 |
| Day 29 | -39.14 ± 6.51 | -31.81 ± 6.86 |
| Day 36 | -46.38 ± 6.67 | -40.10 ± 7.03 |
| Day 43 | -48.92 ± 7.26 | -41.48 ± 7.65 |
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.
| score on a scale | CD5024 0.3% Cream | Placebo |
|---|---|---|
| Week 1 | -0.2 ± 1.1 | -0.2 ± 1.4 |
| Week 2 | -0.6 ± 1.9 | -0.3 ± 1.7 |
| Week 3 | -0.7 ± 2.1 | -0.4 ± 1.9 |
| Week 4 | -1.0 ± 2.3 | -0.3 ± 2.1 |
| Week 5 | -1.0 ± 2.2 | -0.5 ± 2.0 |
| Week 6 | -1.3 ± 2.4 | -0.6 ± 2.1 |
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.
| score on a scale | CD5024 0.3% Cream | Placebo |
|---|---|---|
| Change From Baseline in Pruritus Verbal Rating Scale (VRS) Score at Day 43 | -.31 ± 0.79 | -.13 ± 0.74 |
Collected over Up to Week 9. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CD5024 0.3% Cream | 0/32 (0%) | 0/32 (0%) | 16/32 (50%) |
| Placebo | 0/31 (0%) | 0/31 (0%) | 21/31 (67.7%) |
| Event | CD5024 0.3% Cream | Placebo |
|---|---|---|
| NasopharyngitisInfections and infestations | 6/32 | 10/31 |
| Abdominal painGastrointestinal disorders | 0/32 | 2/31 |
| MyalgiaMusculoskeletal and connective tissue disorders | 0/32 | 2/31 |
| Dermatitis atopicSkin and subcutaneous tissue disorders | 2/32 | 2/31 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 0/32 | 2/31 |
| Upper respiratory tract infectionInfections and infestations | 2/32 | 1/31 |
| HeadacheNervous system disorders | 2/32 | 1/31 |
| GastroenteritisInfections and infestations | 1/32 | 1/31 |
| Urinary tract infectionInfections and infestations | 0/32 | 1/31 |
| Tinea crurisInfections and infestations | 0/32 | 1/31 |
The Intent-to-treat (ITT) efficacy analysis set was defined as any participants who are randomized.
| Age, Continuous(years) | CD5024 0.3% Cream | Placebo | Total |
|---|---|---|---|
| Mean | 27.2 ± 9.19 | 30.0 ± 10.77 | 28.6 ± 9.98 |
| Sex: Female, Male(Participants) | CD5024 0.3% Cream | Placebo | Total |
|---|---|---|---|
| Female | 21 | 26 | 47 |
| Male | 11 | 5 | 16 |
| Race (NIH/OMB)(Participants) | CD5024 0.3% Cream | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 5 | 3 | 8 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 5 | 6 |
| White | 25 | 23 | 48 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Eczema Area and Severity Index (EASI) Score(score on a scale) | CD5024 0.3% Cream | Placebo | Total |
|---|---|---|---|
| Mean | 5.341 ± 2.432 | 5.371 ± 2.652 | 5.356 ± 2.542 |
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