Comparison of Duac® Gel And Differin® Gel in Mild to Moderate Acne Vulgaris
Information source: Stiefel Laboratories
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acne Vulgaris
Intervention: Duac® Gel / Differin® Gel (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Stiefel Laboratories Official(s) and/or principal investigator(s):
A Chu, MB BS, FRCP, Principal Investigator, Affiliation: Hammersmith Hospital, London
A Langner, MD, DSc, Principal Investigator, Affiliation: Iwolang spoo, Warsaw
Summary
Comparing the efficacy and safety of a gel formulation containing a combination of
clindamycin phosphate (equivalent to 1% clindamycin) and benzoyl peroxide (5%) once daily
with a gel containing 0. 1% adapalene once daily in the treatment of acne vulgaris of mild to
moderate severity.
Clinical Details
Official title: Multi-Centre, Single-Blind, Parallel Group, Clinical Evaluation of the Efficacy and Safety of Duac® Gel And Differin® Gel in the Topical Treatment of Mild to Moderate Acne Vulgaris
Study design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Percentage change from baseline of inflammatory lesion counts at week 2
Secondary outcome: Absolute change from baseline of inflammatory lesion counts at week 2.Absolute change and percentage change from baseline of inflammatory lesion counts at weeks 1, 4, 8 and 12. Absolute change and percentage change from baseline of non-inflammatory lesion counts and total lesion counts at weeks 1, 2, 4, 8 and 12. Also, acne grade and global change score at weeks 1, 2, 4, 8 and 12 will be investigated. Patient’s self-rating assessment at weeks 1, 2, 4, 8 and 12.
Detailed description:
Title: A Multi-Centre, Single-Blind, Parallel Group, Clinical Evaluation of the Efficacy and
Safety of Duac® Gel (a Gel Containing Clindamycin Phosphate [Equivalent to 1% Clindamycin]
and 5% Benzoyl Peroxide) And Differin® Gel (a Gel Containing 0. 1% Adapalene) in the Topical
Treatment of Mild to Moderate Acne Vulgaris
Objectives: To compare the efficacy and safety of a gel formulation containing a combination
of clindamycin phosphate (equivalent to 1% clindamycin) and benzoyl peroxide (5%) once daily
with a gel containing 0. 1% adapalene once daily in the treatment of acne vulgaris of mild to
moderate severity.
Study methodology: Randomised, comparator-controlled, single-blind trial. The Investigators/
Assessors will be blinded to the treatment received.
Study population: Male and female patients, aged 12-39, with mild to moderate acne vulgaris.
Eligibility
Minimum age: 12 Years.
Maximum age: 39 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Patients with mild to moderate acne vulgaris of the face with at least 15 inflammatory
lesions and/or non-inflammatory lesions, but no more than three nodulocystic lesions
and an acne grade of greater than 2. 0 and less than 7. 0 (The Leeds Revised Acne
Grading System7).
2. Patients of either sex aged between 12 and 39 years, inclusive.
3. Patients who are willing and able to provide written informed consent, after being
informed of all the pertinent aspects of the trial. In the case of patients aged under
16 years of age, parental or guardian consent must be obtained in addition to patient
assent.
4. Patients agreeing not to use sun-beds or undergo any UV light treatment for 4 weeks
prior to entering the study and to minimise the amount of exposure to direct sunlight
for the duration of the study.
5. Patients agreeing to minimise their alcohol consumption throughout the study, with a
limit of 14 units per week.
Exclusion Criteria:
1. Female patients who are pregnant, breast-feeding, or sexually active and not using
reliable contraception and/or not prepared to do so for the duration of the trial (a
negative pregnancy test must be confirmed at Visit 1 and at the end of the study, for
all females if menarche has occurred).
2. Patients using anti-androgen containing contraceptives.
3. Patients who, during the past month, have received oral or topical steroids, oral or
topical antibiotics, or acne treatment of any type, including natural or artificial UV
therapy.
4. Patients who have a history of hypersensitivity or idiosyncratic reaction to
clindamycin phosphate, benzoyl peroxide, adapalene or any components of the study
medications.
5. Patients using, or having used in the past month, any significant concomitant
medication which might affect their acne, as judged by the Investigator.
6. Patients with severe systemic diseases (e. g., severely impaired renal or liver
function, severe cardiovascular, neurological disease, or any other diseases that may
interfere with the evaluation of the study medications). This also applies to patients
with psoriasis, acne rosacea, allergic rashes, bacterial, viral or fungal infections
of the facial skin, or other diseases of the facial skin.
7. Patients with a history of regional enteritis or ulcerative colitis, or a history of
antibiotic-associated colitis.
8. Patients who have a history of photosensitivity.
9. Patients who are unreliable or unlikely to be available for the duration of the
follow-up.
10. Patients who have participated in a clinical trial involving a drug within 30 days of
recruitment into the study (or are likely to do so at any time during their
participation).
11. Patients who are either an immediate family member, or a colleague, of study
personnel.
12. Patients who already have a member of their household entered onto this trial.
Locations and Contacts
Prof A Langner, Warsaw 00710, Poland
Dr A Chu, London W12 0NN, United Kingdom
Dr V Goulden, Leeds LS1 3EX, United Kingdom
Additional Information
Starting date: December 2004
Ending date: August 2005
Last updated: September 9, 2005
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