Acne VulgarisPhase 4NCT01231334
A Study Comparing Aczone® Plus Differin® Versus Duac® Plus Differin® in Patients With Severe Facial Acne
A Phase 4 study testing Dapsone plus Adapalene and Clindamycin/benzoyl peroxide plus Adapalene in people with Acne Vulgaris, run by Allergan at 1 site in United States.
Trial summary
A study comparing the topical application of Aczone® plus Differin® versus Duac® plus Differin® in patients with severe facial acne (facial acne vulgaris). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Dapsone plus Adapalene and Clindamycin/benzoyl peroxide plus Adapalene
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Jun 2011
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Severe facial acne (acne vulgaris)
Who cannot join
- History of significant anemia or hemolysis
- History of enteritis (eg, regional enteritis, ulcerative colitis, pseudomembranous colitis, antibiotic-associated colitis)
- History of lupus, rosacea, or seborrheic dermatitis
Trial locations and contacts
1 site in 1 country.
About this study
A study comparing the topical application of Aczone® plus Differin® versus Duac® plus Differin® in patients with severe facial acne (facial acne vulgaris).
- Conditions
- Acne Vulgaris
- Being tested
- Dapsone plus Adapalene, Clindamycin/benzoyl peroxide plus Adapalene
- 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 plus AdapaleneDrug
Also called Aczone® Gel 5%, Differin® 0.3% Gel
Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks.
Clindamycin/benzoyl peroxide plus AdapaleneDrug
Also called Duac® Topical Gel, Differin® 0.3% Gel
Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Aczone® Gel 5% plus Differin® 0.3% Gel | Active comparator | Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks. Receives: Drug: Dapsone plus Adapalene |
| Duac® Topical Gel plus Differin® 0.3% Gel | Active comparator | Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks. Receives: Drug: Clindamycin/benzoyl peroxide plus Adapalene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With at Least a One Point Decrease in the Global Acne Assessment Score (GAAS) at Week 12
GAAS was conducted by the investigator at Baseline and Week 12. The patient's facial acne was evaluated on a 5 point scale 0=None (no evidence of acne), 1=Minimal (few lesions), 2=Mild (several to many non-inflammatory lesions; few inflammatory lesions), 3=Moderate (many lesions) to 4=Severe (Significant degree of inflammatory disease; papules/pustules present, few nodulo-cystic lesions; comedones may be present). Papules/nodules are round, solid elevations of the skin with no visible fluid. The percentage of participants with at least a one point decrease (improvement) in GAAS was calculated.
Measured: Baseline, Week 12
Secondary outcomes (6)
Change From Baseline in Global Acne Assessment Score (GAAS) at Week 12
GAAS was conducted by the investigator. The patient's facial acne was evaluated on a 5 point scale 0=None (no evidence of acne), 1=Minimal (few lesions), 2=Mild (several to many non-inflammatory lesions; few inflammatory lesions), 3=Moderate (many lesions) to 4=Severe (Significant degree of inflammatory disease; papules/pustules present, few nodulo-cystic lesions; comedones may be present). Papules and nodules are round, solid elevations of the skin with no visible fluid. A negative change from baseline indicates improvement.
Measured: Baseline, Week 12
Percentage of Participants at Week 12 Having at Least a One Point Decrease in Overall Disease Severity
The overall disease severity was evaluated by the investigator at Baseline and Week 12 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. The percentage of participants with at least a one point decrease (improvement) from baseline is calculated.
Measured: Baseline, Week 12
Percent Change From Baseline in Inflammatory Lesion Counts at Week 12
Percent 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
Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12
Percent 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
Percent Change From Baseline in Total Lesion Count at Week 12
Percent change in total lesion counts: inflammatory (papules, pustules and nodules) and non-inflammatory (comedones) lesion counts from baseline. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters ) and nodules are larger (greater than 5 or 10 millimeters). Pustules are small elevations of the skin containing cloudy material. Comedones are small bumps on the skin caused by acne and found at the opening of a skin pore. A negative change from baseline indicates a reduction in lesion counts (improvement).
Measured: Baseline, Week 12
Percentage of Participants Demonstrating a ≥ 1 Category Increase in Tolerability From Baseline at Week 12
The investigator rated the patient's current symptoms of erythema, dryness, peeling, and oiliness on a 5 point scale from 0 (Absent) to 4 (Severe). The investigator rated the symptoms of pruritus and burning since last visit on a 6 point scale of 0 (Absent) to 5 (Severe)-interfering with daily activities. Percentage of participants demonstrating a ≥1 category increase (improvement) in tolerability from baseline is calculated.
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 posted1 Nov 2010 (estimated)
- Study startAug 2010
- Primary completionJun 2011
- Study completionJun 2011
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
- 286 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
- NCT01231334
- Sponsor's protocol ID
- MA-ACZ1001
- Status last verified
- Jun 2012
- First submitted
- 28 Oct 2010
- Last updated
- 27 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Comparing Aczone® Plus Differin® Versus Duac® Plus Differin® in Patients With Severe Facial Acne
- ClinicalTrials.gov ID
- NCT01231334
- Acronym / sponsor ID
- MA-ACZ1001
- Conditions
- Acne Vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 1 Nov 2010 (estimated)
- Results
- Posted 27 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study comparing the topical application of Aczone® plus Differin® versus Duac® plus Differin® in patients with severe facial acne (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 |
|---|---|---|
| Aczone® Gel 5% plus Differin® 0.3% Gel | Active comparator | Drug: Dapsone plus AdapaleneDapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks. |
| Duac® Topical Gel plus Differin® 0.3% Gel | Active comparator | Drug: Clindamycin/benzoyl peroxide plus AdapaleneClindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Severe facial acne (acne vulgaris)
Key exclusion criteria (3 listed)
- History of significant anemia or hemolysis
- History of enteritis (eg, regional enteritis, ulcerative colitis, pseudomembranous colitis, antibiotic-associated colitis)
- History of lupus, rosacea, or seborrheic dermatitis
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 plus AdapaleneAlso: Aczone® Gel 5%, Differin® 0.3% GelDapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks. | Drug | Aczone® Gel 5% plus Differin® 0.3% Gel |
| Clindamycin/benzoyl peroxide plus AdapaleneAlso: Duac® Topical Gel, Differin® 0.3% GelClindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks | Drug | Duac® Topical Gel plus Differin® 0.3% Gel |
Primary outcome
Percentage of Participants With at Least a One Point Decrease in the Global Acne Assessment Score (GAAS) at Week 12
Time frame: Baseline, Week 12
GAAS was conducted by the investigator at Baseline and Week 12. The patient's facial acne was evaluated on a 5 point scale 0=None (no evidence of acne), 1=Minimal (few lesions), 2=Mild (several to many non-inflammatory lesions; few inflammatory lesions), 3=Moderate (many lesions) to 4=Severe (Significant degree of inflammatory disease; papules/pustules present, few nodulo-cystic lesions; comedones may be present). Papules/nodules are round, solid elevations of the skin with no visible fluid. The percentage of participants with at least a one point decrease (improvement) in GAAS was calculated.
6 secondary outcomes
Change From Baseline in Global Acne Assessment Score (GAAS) at Week 12
Time frame: Baseline, Week 12
Percentage of Participants at Week 12 Having at Least a One Point Decrease in Overall Disease Severity
Time frame: Baseline, Week 12
Percent Change From Baseline in Inflammatory Lesion Counts at Week 12
Time frame: Baseline, Week 12
Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12
Time frame: Baseline, Week 12
Percent Change From Baseline in Total Lesion Count at Week 12
Time frame: Baseline, Week 12
Percentage of Participants Demonstrating a ≥ 1 Category Increase in Tolerability From Baseline 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 27 Jul 2012.
- 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 plus Adapalene and Clindamycin/benzoyl peroxide plus Adapalene 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 1 inclusion and 3 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 27 Jul 2012. 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 27 Jul 2012). 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?
Percentage of Participants With at Least a One Point Decrease in the Global Acne Assessment Score (GAAS) 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 27 Jul 2012.