Acne VulgarisPhase 4NCT00835198
Dapsone Gel 5% and Tretinoin Gel 0.025% Versus Tretinoin Gel 0.025% Monotherapy for Facial Acne Vulgaris
A Phase 4 study testing Dapsone; Tretinoin and Tretinoin in people with Acne Vulgaris, run by Allergan at 1 site in United States.
Trial summary
A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tretinoin gel 0.025% compared with tretinoin gel 0.025% monotherapy in treating moderate to severe facial acne vulgaris Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Dapsone; Tretinoin and Tretinoin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Aug 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Facial acne vulgaris characterized by the following:
- 30-100 facial inflammatory lesions; and, 25-100 facial non-inflammatory lesions;
- Stable disease, non-rapidly regressing facial acne vulgaris; and, less than or equal to 3 nodules and/or cysts (diameter greater than or equal to 1cm)
- Female subjects of childbearing potential must have a negative pregnancy test at baseline and practice reliable method of contraception throughout the study
Who cannot join
- Non-compliance with washout period;
- History of clinically significant anemia or hemolysis;
- Skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris;
- Allergy or sensitivity to any component of the test medications
Trial locations and contacts
1 site in 1 country.
About this study
A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tretinoin gel 0.025% compared with tretinoin gel 0.025% monotherapy in treating moderate to severe facial acne vulgaris
- Conditions
- Acne Vulgaris
- Being tested
- Dapsone; Tretinoin, Tretinoin
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapsone; TretinoinDrug
Also called Aczone Gel 5%; Tretin-X Gel 0.025%
Dapsone topical gel 5%, 1 pea-size amount BID x 12 weeks and Tretinoin gel 0.025%, 1 pea-size amount QD x 12 weeks
TretinoinDrug
Also called Tretin-X Gel 0.025%
Tretinoin gel 0.025%, 1 pea-size amount QD x 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Dapsone gel 5% and Tretinoin gel 0.025% Receives: Drug: Dapsone; Tretinoin |
| 2 | Active comparator | Tretinoin gel 0.025% Receives: Drug: Tretinoin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12
Change from baseline in inflammatory lesion counts (papules, pustules and nodules) at week 12. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters in width and depth) and nodules are larger (greater than 5 or 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).
Measured: Baseline, Week 12
Secondary outcomes (3)
Change From Baseline in Investigator Global Assessment at Week 12
Change from baseline in the Investigator Global Assessment (IGA) at week 12. The IGA is a 5-point scale used by the investigator to assess overall acne severity, where 0 equals clear skin (no evidence of acne) and 4 equals severe acne. A negative number change from baseline indicates a reduction in acne severity (improvement).
Measured: Baseline, Week 12
Change From Baseline in Overall Disease Severity at Week 12
Change from baseline in overall disease severity at week 12. The overall disease severity was evaluated by the investigator using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness and skin condition), where 0=no acne lesions and 6=most severe acne. A negative number change from baseline indicates a reduction in overall acne disease severity (improvement).
Measured: Baseline, Week 12
Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12
Change from baseline in non-inflammatory lesion counts (open/closed comedones) at week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as a blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or "pimples") lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts (improvement).
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startDec 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Who is masked
- Investigator
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00835198
- Sponsor's protocol ID
- MA-ACZ0801
- Status last verified
- Sep 2011
- First submitted
- 30 Jan 2009
- Last updated
- 31 Oct 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dapsone Gel 5% and Tretinoin Gel 0.025% Versus Tretinoin Gel 0.025% Monotherapy for Facial Acne Vulgaris
- ClinicalTrials.gov ID
- NCT00835198
- Acronym / sponsor ID
- MA-ACZ0801
- Conditions
- Acne Vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 3 Feb 2009 (estimated)
- Results
- Posted 31 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tretinoin gel 0.025% compared with tretinoin gel 0.025% monotherapy in treating moderate to severe facial acne vulgaris
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Dapsone; TretinoinDapsone gel 5% and Tretinoin gel 0.025% |
| 2 | Active comparator | Drug: TretinoinTretinoin gel 0.025% |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Facial acne vulgaris characterized by the following:
- Female subjects of childbearing potential must have a negative pregnancy test at baseline and practice reliable method of contraception throughout the study
Key exclusion criteria (4 listed)
- Non-compliance with washout period;
- History of clinically significant anemia or hemolysis;
- Skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris;
- Allergy or sensitivity to any component of the test medications
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 |
|---|---|---|
| Dapsone; TretinoinAlso: Aczone Gel 5%; Tretin-X Gel 0.025%Dapsone topical gel 5%, 1 pea-size amount BID x 12 weeks and Tretinoin gel 0.025%, 1 pea-size amount QD x 12 weeks | Drug | 1 |
| TretinoinAlso: Tretin-X Gel 0.025%Tretinoin gel 0.025%, 1 pea-size amount QD x 12 weeks | Drug | 2 |
Primary outcome
Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12
Time frame: Baseline, Week 12
Change from baseline in inflammatory lesion counts (papules, pustules and nodules) at week 12. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters in width and depth) and nodules are larger (greater than 5 or 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).
3 secondary outcomes
Change From Baseline in Investigator Global Assessment at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Overall Disease Severity at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12
Time frame: Baseline, Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Director study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapsone; Tretinoin and Tretinoin in people with Acne Vulgaris, run by Allergan at 1 site in United States.
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 4 inclusion and 4 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 31 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 31 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12 (time frame: Baseline, Week 12). 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 31 Oct 2011.