Efficacy and Safety Study of CD2027 Ointment 3 Mcg/g Twice Daily Treatment for Adults With at Least Moderate Atopic Dermatitis - Full Text View

Purpose

This is 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 subjects 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% - 20% involved BSA (excluding Head/Neck) in adult subjects with at least moderate atopic dermatitis.

Condition	Intervention	Phase
Atopic Dermatitis	Drug: CD 2027 Drug: CD 2027 Vehicle	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Further study details as provided by Galderma:

Primary Outcome Measures:

Total Sum Score (TSS)of Target Lesion [ Time Frame: at Week 4 ] [ Designated as safety issue: No ]
Total Sum Score (TSS) on the Target Lesion at Week 4 or Early Termination adjusted on Baseline (Sum of Erythema, Excoriation, Papulation/Induration, Oozing/Crusting and Lichenification of Target Lesion).

Scale values range from 0 - 3; 0 is minumal (best) and 3 is maximum (worst). Unit is used as score on a scale. Total possible minimum score is 0. Total possible maximum score is 15.

Secondary Outcome Measures:

Percent Change in TSS [ Time Frame: from Baseline to Week 4 ] [ Designated as safety issue: No ]

Enrollment:	102
Study Start Date:	May 2009
Study Completion Date:	November 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CD 2027 Topical Ointment	Drug: CD 2027 Topical Ointment; two applications daily, once in the morning and once in the evening for 4 weeks
Placebo Comparator: CD 2027 Vehicle Topical Ointment	Drug: CD 2027 Vehicle Topical Ointment, two applications daily, once in the morning and once in the evening for 4 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female subject, 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:is representative of the subject's disease state,is not located on the hands, feet or genitalia,measures at least 10 cm²,presents 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 subject has albumin-adjusted calcium above the upper normal range from screening evaluation.
The subject has history/signs/symptoms suggestive of an abnormality of calcium homeostasis (such as hyperparathyroidism, Paget's disease, adrenal insufficiency, hyperthyroidism)
The subject has signs/symptoms of urinary stones or has a history of urinary stones within the past 5 years prior to the Screening Visit

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00919763

Locations

United States, Arkansas
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
United States, California
Therapeutics Clinical Research, Inc.
San Diego, California, United States, 92123
United States, Colorado
Colorado Medical Research Center, Inc.
Denver, Colorado, United States, 80120
Longmont Medical Research Network
Longmont, Colorado, United States, 80501
United States, Kentucky
Dermatology Specialists PSC
Louisville, Kentucky, United States, 40202
United States, Minnesota
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
United States, New Mexico
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106
United States, New York
Helendale Dermatology & Medical Spa, LLC
Rochester, New York, United States, 104609
United States, Oregon
Oregon Medical Research Center
Portland, Oregon, United States, 97223
Oregon Dermatology & Research Center
Portland, Oregon, United States, 97210
United States, Texas
Arlington Research Center, Inc.
Arlington, Texas, United States, 76011
DermResearch Inc.
Austin, Texas, United States, 78759
J&S Studies, Inc.
College Station, Texas, United States, 77845

Sponsors and Collaborators

Galderma

Investigators

Study Director:

Michael Graeber, MD

Galderma

More Information

No publications provided

Responsible Party:	Galderma
ClinicalTrials.gov Identifier:	NCT00919763 History of Changes
Other Study ID Numbers:	RD.06.SPR.18158
Study First Received:	June 9, 2009
Results First Received:	January 19, 2012
Last Updated:	May 29, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Galderma:

Atopic Dermatitis

Additional relevant MeSH terms:

Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn

Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013