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

Atopic Dermatitis Clinical Trial

Official title:

A Four-Week, Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CD2027 Ointment 3 mcg/g Twice Daily in the Treatment of Adults With at Least Moderate Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00919763
• Other study ID #: RD.06.SPR.18158
• Status: Completed
• Phase: Phase 2
• Start date: May 21, 2009
• Est. completion date: October 1, 2009

Study information

• Verified date: May 2022
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: October 1, 2009
• Est. primary completion date: October 1, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• CD2027 Ointment 3 mcg/g, twice daily
Topical Ointment
• Vehicle Ointment, twice daily
Topical Ointment

Locations

Country	Name	City	State
United States	Academic Dermatology Associates	Albuquerque	New Mexico
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	Colorado Medical Research Center, Inc.	Denver	Colorado
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Burke Pharmaceutical Research	Hot Springs	Arkansas
United States	Longmont Medical Research Network	Longmont	Colorado
United States	Dermatology Specialists PSC	Louisville	Kentucky
United States	International Dermatology Research, Inc.	Miami	Florida
United States	Oregon Dermatology & Research Center	Portland	Oregon
United States	Oregon Medical Research Center	Portland	Oregon
United States	Helendale Dermatology & Medical Spa, LLC	Rochester	New York
United States	Therapeutics Clinical Research, Inc.	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Severity Score (TSS) of Target Lesion at Baseline and 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.	Baseline, Week 4
Secondary	Change From Baseline in Total Severity Score (TSS) for Individual Signs at 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).	Baseline, Week 4
Secondary	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	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.	Baseline, Week 1, Week 2, Week 3, Week 4
Secondary	Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 1, 2, 3, 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.	Baseline, Week1, Week2, Week 3, Week 4