Status:
COMPLETED
Efficacy and Safety Study of CD2027 Ointment 3 Microgram Per Gram (mcg/g) Twice Daily Treatment for Adults With at Least Moderate Atopic Dermatitis
Lead Sponsor:
Galderma R&D
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 21 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00919763
Start Date
May 21 2009
End Date
October 1 2009
Last Update
July 19 2022
Active Locations (14)
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1
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
2
Therapeutics Clinical Research, Inc.
San Diego, California, United States, 92123
3
Colorado Medical Research Center, Inc.
Denver, Colorado, United States, 80120
4
Longmont Medical Research Network
Longmont, Colorado, United States, 80501