Efficacy and Safety Study of CD2027 Ointment 3 Microgram Per Gram (mcg/g) Twice Daily Treatment for Adults With at Least Moderate Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Interventions
- Drug: CD2027 Ointment 3 mcg/g, twice dailyDrug: Vehicle Ointment, twice daily
- Registration Number
- NCT00919763
- Lead Sponsor
- Galderma R&D
- Brief Summary
This was a multi-center, randomized, double-blind, parallel group study. Efficacy Objectives: To evaluate the efficacy of CD2027 ointment 3 mcg/g applied twice daily over 4 weeks versus its vehicle in adult participants with at least moderate atopic dermatitis.
Safety objective: To evaluate safety of CD2027 ointment 3 mcg/g when applied twice daily over 4 weeks versus its vehicle on 5 percent (%) - 20% involved Body Surface Area (BSA) (excluding Head/Neck) in adult participants with at least moderate atopic dermatitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
- Male or female participant, 18 years of age or older
- Clinical diagnosis of atopic dermatitis according to Hanifin and Rajka criteria, of at least moderate intensity according to Investigator Global Assessment (IGA greater or equal to 3)
- Body surface affected by the disease between 5% and 20% of total BSA, based on Rule of Nine's, excluding Head/Neck
- At least one area (Target Lesion) which was representative of the participant's disease state, was not located on the hands, feet or genitalia, measures at least 10 cm^2, presented a Total Severity Score of at least 6/15 (total severity score defined as the sum of Erythema, Excoriation, Papulation/Induration, Oozing/Crusting and Lichenification) with oozing/crusting severity at most 1
- The participant had albumin-adjusted calcium above the upper normal range from screening evaluation
- The participant had history/signs/symptoms suggestive of an abnormality of calcium homeostasis (such as hyperparathyroidism, Paget's disease, adrenal insufficiency, hyperthyroidism)
- The participant had signs/symptoms of urinary stones or has a history of urinary stones within the past 5 years prior to the Screening Visit
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CD2027 Ointment 3 mcg/g, twice daily CD2027 Ointment 3 mcg/g, twice daily Participants applied 3 mcg/g CD2027 Ointment (up to 10 gram per application) topically, twice daily (at least 8 hours apart) over 4 weeks on atopic dermatitis lesions. Vehicle Ointment, twice daily Vehicle Ointment, twice daily Participants applied Vehicle Ointment (up to 10 gram per application) topically, twice daily (at least 8 hours apart) over 4 weeks on atopic dermatitis lesions.
- Primary Outcome Measures
Name Time Method Total Severity Score (TSS) of Target Lesion at Baseline and Week 4 Baseline, Week 4 TSS comprised of the sum of an assessment of erythema, excoriation, exudation, lichenification and pruritus, each on a scale of 0 to 3 to give a maximum score of 15; 0 (best) and 3 (worst) indicated total possible minimum score was 0 and total possible maximum score was 15. Lower score meant improvement in condition and higher score indicated worsening of condition.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Total Severity Score (TSS) for Individual Signs at Week 4 Baseline, Week 4 TSS comprised of the sum of an assessment of erythema, excoriation, exudation, lichenification and pruritus, each on a scale of 0 to 3 to give a maximum score of 15; 0 (best) and 3 (Worst) indicated total possible minimum score was 0 and total possible maximum score was 15. Data for individual signs is reported in this outcome measure. Lower score meant improvement in condition and higher score indicated severity (worsening of condition) for each individual sign.
Erythema was evaluated on a four point scale of 0 to 3 where (0=none, 1=mild, 2=moderate, 3=severe). Excoriation evaluated on a four point scale of 0 to 3 where (0=none, 1=mild, 2=moderate, 3=severe). Exudation was evaluated on a four point scale of 0 to 3 where (0=none, 1=mild, 2=moderate, 3=severe). Lichenification was evaluated on a four point scale of 0 to 3 where (0=none, 1=mild, 2=moderate, 3=severe). Pruritus was evaluated on a four point scale of 0 to 3 where (0=none, 1=mild, 2=moderate, 3=severe).Number of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Failure From Baseline of Greater Than 1 Points Over Week 4 Baseline, Week 1, Week 2, Week 3, Week 4 IGA was an assessment scale used to determine severity of Atopic Dermatitis (AD) and clinical response to treatment on a 5-point scale (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score of "0" or "1" and a failure from baseline of greater than (\>1) points over 4 weeks were reported.
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 1, 2, 3, 4 Baseline, Week1, Week2, Week 3, Week 4 The EASI score quantifies the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no eruption) to 6 (\>90%-100% eruption). The total score was the sum of the four body-region scores, maximum=72, minimum=0, Higher scores indicated greater disease severity.
Trial Locations
- Locations (14)
Helendale Dermatology & Medical Spa, LLC
🇺🇸Rochester, New York, United States
Minnesota Clinical Study Center
🇺🇸Fridley, Minnesota, United States
Therapeutics Clinical Research, Inc.
🇺🇸San Diego, California, United States
Longmont Medical Research Network
🇺🇸Longmont, Colorado, United States
International Dermatology Research, Inc.
🇺🇸Miami, Florida, United States
Arlington Research Center, Inc.
🇺🇸Arlington, Texas, United States
Colorado Medical Research Center, Inc.
🇺🇸Denver, Colorado, United States
Oregon Medical Research Center
🇺🇸Portland, Oregon, United States
Burke Pharmaceutical Research
🇺🇸Hot Springs, Arkansas, United States
Oregon Dermatology & Research Center
🇺🇸Portland, Oregon, United States
Dermatology Specialists PSC
🇺🇸Louisville, Kentucky, United States
Academic Dermatology Associates
🇺🇸Albuquerque, New Mexico, United States
DermResearch Inc.
🇺🇸Austin, Texas, United States
J&S Studies, Inc.
🇺🇸College Station, Texas, United States