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Comparison of Duac® Gel And Differin® Gel in Mild to Moderate Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Duac® Gel / Differin® Gel
Sponsored by
Stiefel, a GSK Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Mild to Moderate

Eligibility Criteria

12 Years - 39 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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). Patients of either sex aged between 12 and 39 years, inclusive. 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. 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. Patients agreeing to minimise their alcohol consumption throughout the study, with a limit of 14 units per week. Exclusion Criteria: 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). Patients using anti-androgen containing contraceptives. 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. Patients who have a history of hypersensitivity or idiosyncratic reaction to clindamycin phosphate, benzoyl peroxide, adapalene or any components of the study medications. Patients using, or having used in the past month, any significant concomitant medication which might affect their acne, as judged by the Investigator. 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. Patients with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis. Patients who have a history of photosensitivity. Patients who are unreliable or unlikely to be available for the duration of the follow-up. 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). Patients who are either an immediate family member, or a colleague, of study personnel. Patients who already have a member of their household entered onto this trial.

Sites / Locations

  • Prof A Langner
  • Dr V Goulden
  • Dr A Chu

Outcomes

Primary Outcome Measures

Percentage change from baseline of inflammatory lesion counts at week 2

Secondary Outcome Measures

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.

Full Information

First Posted
September 9, 2005
Last Updated
May 24, 2017
Sponsor
Stiefel, a GSK Company
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00160394
Brief Title
Comparison of Duac® Gel And Differin® Gel in Mild to Moderate Acne Vulgaris
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 Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stiefel, a GSK Company
Collaborators
GlaxoSmithKline

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Mild to Moderate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Duac® Gel / Differin® Gel
Primary Outcome Measure Information:
Title
Percentage change from baseline of inflammatory lesion counts at week 2
Secondary Outcome Measure Information:
Title
Absolute change from baseline of inflammatory lesion counts at week 2.
Title
Absolute change and percentage change from baseline of inflammatory lesion counts at weeks 1, 4, 8 and 12.
Title
Absolute change and percentage change from baseline of non-inflammatory lesion counts and total lesion counts at weeks 1, 2, 4, 8 and 12.
Title
Also, acne grade and global change score at weeks 1, 2, 4, 8 and 12 will be investigated.
Title
Patient's self-rating assessment at weeks 1, 2, 4, 8 and 12.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Patients of either sex aged between 12 and 39 years, inclusive. 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. 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. Patients agreeing to minimise their alcohol consumption throughout the study, with a limit of 14 units per week. Exclusion Criteria: 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). Patients using anti-androgen containing contraceptives. 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. Patients who have a history of hypersensitivity or idiosyncratic reaction to clindamycin phosphate, benzoyl peroxide, adapalene or any components of the study medications. Patients using, or having used in the past month, any significant concomitant medication which might affect their acne, as judged by the Investigator. 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. Patients with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis. Patients who have a history of photosensitivity. Patients who are unreliable or unlikely to be available for the duration of the follow-up. 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). Patients who are either an immediate family member, or a colleague, of study personnel. Patients who already have a member of their household entered onto this trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A Chu, MB BS, FRCP
Organizational Affiliation
Hammersmith Hospital, London
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
A Langner, MD, DSc
Organizational Affiliation
Iwolang spoo, Warsaw
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prof A Langner
City
Warsaw
ZIP/Postal Code
00710
Country
Poland
Facility Name
Dr V Goulden
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
Dr A Chu
City
London
ZIP/Postal Code
W12 0NN
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Comparison of Duac® Gel And Differin® Gel in Mild to Moderate Acne Vulgaris

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