Efficacy and Safety Study of CD2027 Ointment 3 Microgram Per Gram (mcg/g) Twice Daily Treatment for Adults With at Least Moderate Atopic Dermatitis
NCT ID: NCT00919763
Last Updated: 2022-07-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
102 participants
INTERVENTIONAL
2009-05-21
2009-10-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Aged 2 Years and Older) With Atopic Dermatitis
NCT02118792
Efficacy and Safety of AN2728 Topical Ointment to Treat Adolescents With Atopic Dermatitis
NCT01602341
Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Ages 2 Years and Older) With Atopic Dermatitis
NCT02118766
A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Adults With Atopic Dermatitis
NCT02757729
Efficacy and Safety Study of QLM3003 Ointment in Participants With Mild or Moderate Atopic Dermatitis
NCT06880276
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
CD2027 Ointment 3 mcg/g, twice daily
Topical Ointment
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.
Vehicle Ointment, twice daily
Topical Ointment
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CD2027 Ointment 3 mcg/g, twice daily
Topical Ointment
Vehicle Ointment, twice daily
Topical Ointment
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Galderma R&D
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael Graeber, MD
Role: STUDY_DIRECTOR
Galderma R&D
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RD.06.SPR.18158
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.