Acne VulgarisPhase 4NCT00160394
Comparison of Duac® Gel And Differin® Gel in Mild to Moderate Acne Vulgaris
A Phase 4 study testing Duac® Gel / Differin® Gel in people with Acne Vulgaris, run by Stiefel, a GSK Company at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 39 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Duac® Gel / Differin® Gel
- How many people
- 130 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Dec 2004to Aug 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United Kingdom2 sites
Dr V Goulden
Leeds, LS1 3EX
Dr A Chu
London, W12 0NN
About this study
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
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.
Read the 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.
- Conditions
- Acne Vulgaris
- Being tested
- Duac® Gel / Differin® Gel
- Keywords
- Mild to Moderate
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duac® Gel / Differin® GelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change from baseline of inflammatory lesion counts at week 2
Secondary outcomes (5)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionAug 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stiefel, a GSK Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- A Chu, MB BS, FRCP, Principal investigator, Hammersmith Hospital, LondonA Langner, MD, DSc, Principal investigator, Iwolang spoo, Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00160394
- Sponsor's protocol ID
- S194-INT-04
- Status last verified
- May 2017
- First submitted
- 9 Sep 2005
- Last updated
- 30 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00160394
- Acronym / sponsor ID
- S194-INT-04
- Conditions
- Acne Vulgaris
- Keywords
- Mild to Moderate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- Dec 2004
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 12 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duac® Gel / Differin® Gel | Drug | – |
Primary outcome
Percentage change from baseline of inflammatory lesion counts at week 2
5 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A Chu, MB BS, FRCP principal investigator
Hammersmith Hospital, London
A Langner, MD, DSc principal investigator
Iwolang spoo, Warsaw
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Duac® Gel / Differin® Gel in people with Acne Vulgaris, run by Stiefel, a GSK Company at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change from baseline of inflammatory lesion counts at week 2. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.