Efficacy and Safety Study of CD2027 Ointment 3 Microgram Per Gram (mcg/g) Twice Daily Treatment for Adults With at Least Moderate Atopic Dermatitis

Completed · Phase 2

Conditions studied: Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT00919763

Run by

Galderma R&D

People needed

102

Starts

2009-05-21

Expected to finish

2009-10-01

Last updated by the study team

2022-07-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Burke Pharmaceutical Research — Hot Springs, Arkansas, United States
• Therapeutics Clinical Research, Inc. — San Diego, California, United States
• Colorado Medical Research Center, Inc. — Denver, Colorado, United States
• Longmont Medical Research Network — Longmont, Colorado, United States
• International Dermatology Research, Inc. — Miami, Florida, United States
• Dermatology Specialists PSC — Louisville, Kentucky, United States
• Minnesota Clinical Study Center — Fridley, Minnesota, United States
• Academic Dermatology Associates — Albuquerque, New Mexico, United States
• Helendale Dermatology & Medical Spa, LLC — Rochester, New York, United States
• Oregon Dermatology & Research Center — Portland, Oregon, United States
• Oregon Medical Research Center — Portland, Oregon, United States
• Arlington Research Center, Inc. — Arlington, Texas, United States
• DermResearch Inc. — Austin, Texas, United States
• J&S Studies, Inc. — College Station, Texas, United States

Full record on ClinicalTrials.gov

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