- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03250624
Safety and Efficacy of CD5024 0.3% Cream in Subjects With Atopic Dermatitis
June 27, 2022 updated by: Galderma R&D
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Study application was performed once daily, 7 days a week for 6 weeks.
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Mississauga, Ontario, Canada, L5H 1G9
- Galderma Investigational Site (#8581)
-
Richmond Hill, Ontario, Canada, L4B 1A5
- Galderma Investigational Site (# 8338)
-
Richmond Hill, Ontario, Canada, L4C 9M7
- Galderma Investigational Site (#8587)
-
Windsor, Ontario, Canada, N8W 5L7
- Galderma Investigational Site (# 8060)
-
-
Quebec
-
Montreal, Quebec, Canada, H2K 4L5
- Galderma Investigational Site (#8089)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- The participant was a male or female aged 18 to 60 years old inclusive at Screening.
- The participant presented with a total body surface area (tBSA) less than or equal to (>=) 2 square meter (m^2) at Screening.
- The participant had atopic dermatitis for at least 6 months prior to Day 1. The clinical diagnosis of atopic dermatitis must be confirmed with the criteria of Hanifin and Rajka at the screening visit.
- Atopic dermatitis must be stable for at least one month before the screening visit (according to participant).
- The participant had a Body Surface Area (BSA) affected by AD ranging from 1% inclusive to 10% inclusive at Day 1, excluding scalp and genitals.
- The participant had an overall Investigator's Global Assessment (IGA) score of 3 (moderate) at Day 1;
Exclusion Criteria:
- The participant was a pregnant female, is breastfeeding or intends to conceive a child during the study,
- The participant had any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results (e.g. extensive scaring or pigmented lesion in a treated area), and/or put the participant at significant risk according to Investigator's judgment if he/she participates in the clinical trial (e.g. active cancer, AIDS, insulin-dependent diabetes…) at Screening or Day 1.
- The participant presented with an acute flare of AD at Day 1.
- The participant had active cutaneous bacterial or viral infection in any treated area at baseline (e.g. clinically infected AD) at Screening or Day 1.
- The participant had a history of confounding skin condition (e.g. psoriasis, erythroderma) or a history of Netherton syndrome at Screening.
- The participant had a past history of serious persistent neurological disorders such as seizures, multiple sclerosis, or neurological signs or symptoms at Screening.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 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.
|
Experimental: 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 centimeter square (mg/cm^2) once daily for 6 weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Eczema Area and Severity Index (EASI) Score at Day 43
Time Frame: Baseline, 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change From Baseline in EASI at Each Visit
Time Frame: Baseline, Days 8,15, 22, 29, 36 and 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) points, with the higher scores indicated the worse severity of AD.
All missing values were imputed by LOCF.
|
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)
Time Frame: Days 8, 15, 22, 29, 36 and 43
|
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
Time Frame: Baseline, Days 8, 15, 22, 29, 36 and 43
|
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
Time Frame: Baseline, Days 8, 15, 22, 29, 36 and 43
|
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
Time Frame: Baseline, Weeks 1, 2, 3, 4, 5 and 6
|
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
Time Frame: Baseline, 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2016
Primary Completion (Actual)
June 26, 2017
Study Completion (Actual)
June 26, 2017
Study Registration Dates
First Submitted
August 11, 2017
First Submitted That Met QC Criteria
August 11, 2017
First Posted (Actual)
August 15, 2017
Study Record Updates
Last Update Posted (Actual)
May 1, 2023
Last Update Submitted That Met QC Criteria
June 27, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RD.03.SPR.109696
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atopic Dermatitis
-
Catalysis SLCompletedAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis and Related Conditions | Atopic Dermatitis \(AD\)Serbia
-
Jacob Pontoppidan ThyssenThe Novo Nordic FoundationRecruitingAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis FlareDenmark
-
ShaperonNot yet recruitingAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis of Scalp
-
University of California, San FranciscoSanofi; Regeneron PharmaceuticalsRecruitingEczema | Atopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis and Related ConditionsUnited States
-
PfizerActive, not recruitingEczema | Atopic Dermatitis | Eczema, Atopic | Atopic Dermatitis, UnspecifiedUnited States, Canada, Czechia, Poland
-
AmgenCompletedDermatitis, Atopic DermatitisCanada, United States, Japan
-
Hadassah Medical OrganizationUnknownATOPIC DERMATITIS
-
SanofiCompletedAtopic Dermatitis | Dermatitis AtopicChina
-
SanofiCompletedDermatitis AtopicSaudi Arabia, Kuwait, United Arab Emirates
-
National Institute of Allergy and Infectious Diseases...Atopic Dermatitis Research NetworkCompletedAtopic Dermatitis (AD) | Non-atopic Healthy ControlsUnited States
Clinical Trials on CD5024 0.3% cream
-
Galderma R&DCompleted
-
Arcutis Biotherapeutics, Inc.CompletedChronic Plaque PsoriasisUnited States, Canada
-
Arcutis Biotherapeutics, Inc.CompletedPlaque PsoriasisUnited States
-
Arcutis Biotherapeutics, Inc.CompletedChronic Plaque PsoriasisUnited States, Canada
-
Padagis LLCCompletedPlaque PsoriasisUnited States
-
Arcutis Biotherapeutics, Inc.CompletedChronic Hand EczemaUnited States, Australia, Canada
-
Amorepacific CorporationCompletedSeborrheic Dermatitis
-
Medinova AGCompletedPhlebitis | ThrombophlebitisThailand
-
Arcutis Biotherapeutics, Inc.CompletedMaximal Usage Pharmacokinetics and Safety of ARQ-151 in Children With Plaque Psoriasis (ARQ-151-216)Psoriasis | Plaque PsoriasisUnited States, Canada, Dominican Republic
-
Arcutis Biotherapeutics, Inc.CompletedChronic Plaque PsoriasisUnited States, Canada, Dominican Republic