|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00441415 |
|
Date of registration:
|
27/02/2007 |
|
Primary sponsor: |
|
|
Public title:
|
Efficacy and Safety of Fixed Combination Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris
|
|
Scientific title:
|
Efficacy and Safety of Fixed Combination Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Compared to Clindamycin 0.1% / Benzoyl Peroxide 5% Gel in the Treatment of Acne Vulgaris |
|
Date of first enrolment:
|
February 2007 |
|
Target sample size:
|
272 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00441415 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Alicia BUCKO, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Academic Dermatology Associates - Albuquerque NM - 505-247-4220 |
|
|
Name:
|
Paul YAMAUCHI, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Clinical Research Specialists, Inc. - Santa Monica CA - 310-828-8887 |
|
|
Name:
|
Michael MEURER, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Dresden University - Dresden - Germany |
|
|
Name:
|
Christos ZOUBOULIS, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Hautklinik und Immunologisches Zentrum des Städtischen Klinikum - Dessau - Germany |
|
|
Name:
|
Elisabeth ARTHUR, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Helendale Dermatology - Rochester NY - 585-266-5420 |
|
|
Name:
|
Thomas SCHWARZ, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Klinik fur Dermatologie, Venerologie und Allerologie - Kiel - Germany |
|
|
Name:
|
Steven E. KEMPERS, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Minnesota Clinical Study Center - Fridley MN - 763-571-4200 |
|
|
Name:
|
Harald GOLLNICK, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Otto-von-Guericke University - Magdeburg - Germany |
|
|
Name:
|
Yvonne FRAMBACH, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Universitatsklinikum - Lubeck - Germany |
|
|
Name:
|
Roland KAUFMANN, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Zentrum fur Dermatoligie und Venerologie - Frankfurt - Germany |
| | |
|
Key inclusion & exclusion criteria
|
Male or female Subjects of any race, between the age of 12 and 35 years inclusive, with
acne vulgaris, meeting specific inclusion/exclusion criteria.
Main inclusion criteria:
1. Male or female Subjects of any race, aged 12 to 35 years inclusive, with facial acne
vulgaris,
2. Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the
face,
3. Subjects with a minimum of 30 and a maximum of 100 non-inflammatory lesions (open
comedones and closed comedones) on the face, excluding the nose.
Main exclusion criteria:
1. Subjects with acne cystic lesions,
2. Subjects with acne conglobate, acne fulminancy, secondary acne (chloracne,
drug-induced acne, etc.).
Age minimum:
12 Years
Age maximum:
35 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Acne Vulgaris
|
|
Intervention(s)
|
|
Drug: Adapalene BPO
|
|
Primary Outcome(s)
|
|
Percent change from Baseline in total lesion count (sum of non inflammatory and inflammatory lesions) at week 12.
|
|
Secondary Outcome(s)
|
|
Global severity assessment at each post Baseline visit
|
|
Percent change from Baseline in total inflammatory and non inflammatory lesion counts at each intermediate visit
|
|
Secondary ID(s)
|
|
RD.03.SPR.29058
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|