Acne VulgarisPhase 4NCT02032407

A Study of Dapsone Gel in Females With Skin of Color and Acne Vulgaris

A Phase 4 study testing Dapsone Gel in people with Acne Vulgaris, run by Allergan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will evaluate the effect of dapsone gel in female subjects with skin of color (Fitzpatrick Skin Types IV, V, and VI) with acne vulgaris. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Acne Vulgaris
What is being tested?: Dapsone Gel
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 1 siteUnited States
Study dates: Dec 2013to Sep 2014
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 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of acne vulgaris
Medium to dark complexion (Fitzpatrick Skin Type IV, V or VI)
Willing to avoid excessive or prolonged exposure of the face to ultraviolet light (eg, sunlight, tanning beds) throughout the study

Who cannot join

Received treatment with botulinum toxin of any serotype in the face within 6 months

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Washington D.C., District of Columbia

Other trials in United States

About this study

This study will evaluate the effect of dapsone gel in female subjects with skin of color (Fitzpatrick Skin Types IV, V, and VI) with acne vulgaris.

Conditions: Acne Vulgaris
Being tested: Dapsone Gel
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 GelDrug
Also called Aczone®
Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.

Study groups in NCT02032407
Study group	Role	What they receive
Dapsone Gel	Experimental	Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks. Receives: Drug: Dapsone Gel

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in the Global Assessment of Acne Severity (GAAS) Score by Physician
The investigator evaluated the participant's acne severity using the 5-point GAAS grading scale: 0= No evidence of facial acne vulgaris to 4= Significant degree of inflammatory disease; papules/pustules were a predominant feature; a few nodulo-cystic lesions could have been present; comedones (small pumps on the skin caused by acne) could have been present. A negative change from Baseline indicated improvement.
Measured: Baseline, Week 12

Secondary outcomes (7)

Change From Baseline in the GAAS
The investigator evaluated the participant's acne severity using the 5-point GAAS grading scale: 0= No evidence of facial acne vulgaris to 4= Significant degree of inflammatory disease; papules/pustules were a predominant feature; a few nodulo-cystic lesions could have been present; comedones (small pumps on the skin caused by acne) could have been present. A negative change from Baseline indicated improvement.
Measured: Baseline, Weeks 2 and 6
Percent Change From Baseline in Total Lesion Counts
The investigator evaluated Inflammatory (papule, pustule and nodule/cyst) and Non-inflammatory (blackhead and whitehead) lesions. A papule is a small, red, solid elevation less than 1.0 cm in diameter, a pustule is a small, circumscribed elevation of the skin that contains yellow-white exudate and a nodule/cyst is a circumscribed, elevated, solid lesion generally more than 0.5 cm in diameter with palpable depth. The total lesion count was the sum of the inflammatory and non-inflammatory lesion counts. A negative percent change from baseline indicates a reduction in lesion counts (improvement).
Measured: Baseline, Weeks 2, 6 and 12
Percent Change From Baseline in Inflammatory Lesion Counts
The investigator evaluated Inflammatory lesions (papule, pustule and nodule/cyst). A negative percent change from baseline indicates a reduction in lesion counts (improvement).
Measured: Baseline, Weeks 2, 6 and 12
Percent Change From Baseline in Non-Inflammatory Lesion Counts
The investigator evaluated Non-inflammatory (blackhead and whitehead) lesions. A negative percent change from baseline indicates a reduction in lesion counts (improvement).
Measured: Baseline, Weeks 2, 6 and 12
Percentage of Participants With 0 (None) or 1 (Minimal) on the GAAS
The investigator evaluated the participant's acne severity using the 5-point GAAS grading scale: 0= No evidence of facial acne vulgaris to 4= Significant degree of inflammatory disease; papules/pustules were a predominant feature; a few nodulo-cystic lesions could have been present; comedones (small pumps on the skin caused by acne) could have been present. The percentage of participants with a score of 0=none or 1=minimal is reported.
Measured: Weeks 2, 6 and 12
Acne Symptom and Impact Scale (ASIS) Sign Domain Score
The participant assessed signs of acne vulgaris using the ASIS. The sign domain is a composite of 9 items of the 17 items on the overall scale. Each of the items is answered on a 5-point scale: 0 (best) to 4 (worst). The sign domain score is calculated as the average of the 9 items for a total possible score of 0 to 4. Higher scores indicate the presence of more severe signs of acne.
Measured: Weeks 2, 6 and 12
ASIS Impact Domain Score
The participant assessed the impact of acne vulgaris using the ASIS. The impact domain is a composite of 8 items assessing the psychosocial impacts (6 items emotional and 2 items social) of the 17 items on the overall scale. Each of the items is answered on a 5-point scale: 0 (best) to 4 (worst). The impact domain score is calculated as the average of the 8 items for a total possible score of 0 to 4. Higher scores on the ASIS Impact Domain indicate greater negative impact of acne on health-related quality of life and appearance.
Measured: Weeks 2, 6 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2013Sep 2014

First posted10 Jan 2014 (estimated)
Study startDec 2013
Primary completionJun 2014
Study completionSep 2014

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02032407
Sponsor's protocol ID: GMA-ACZ-13-001
Status last verified: Aug 2015
First submitted: 8 Jan 2014
Last updated: 19 Aug 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
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All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of Dapsone Gel in Females With Skin of Color and Acne Vulgaris
ClinicalTrials.gov ID: NCT02032407
Acronym / sponsor ID: GMA-ACZ-13-001
Conditions: Acne Vulgaris
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Dec 2013
Primary completion: Jun 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 10 Jan 2014 (estimated)
Results: Posted 19 Aug 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will evaluate the effect of dapsone gel in female subjects with skin of color (Fitzpatrick Skin Types IV, V, and VI) with acne vulgaris.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Dapsone Gel	Experimental	Drug: Dapsone GelDapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Diagnosis of acne vulgaris
Medium to dark complexion (Fitzpatrick Skin Type IV, V or VI)
Willing to avoid excessive or prolonged exposure of the face to ultraviolet light (eg, sunlight, tanning beds) throughout the study

Key exclusion criteria (1 listed)

Received treatment with botulinum toxin of any serotype in the face within 6 months

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 GelAlso: Aczone®Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.	Drug	Dapsone Gel

Primary outcome

Change From Baseline in the Global Assessment of Acne Severity (GAAS) Score by Physician
Time frame: Baseline, Week 12
The investigator evaluated the participant's acne severity using the 5-point GAAS grading scale: 0= No evidence of facial acne vulgaris to 4= Significant degree of inflammatory disease; papules/pustules were a predominant feature; a few nodulo-cystic lesions could have been present; comedones (small pumps on the skin caused by acne) could have been present. A negative change from Baseline indicated improvement.

7 secondary outcomes

Change From Baseline in the GAAS
Time frame: Baseline, Weeks 2 and 6
Percent Change From Baseline in Total Lesion Counts
Time frame: Baseline, Weeks 2, 6 and 12
Percent Change From Baseline in Inflammatory Lesion Counts
Time frame: Baseline, Weeks 2, 6 and 12
Percent Change From Baseline in Non-Inflammatory Lesion Counts
Time frame: Baseline, Weeks 2, 6 and 12
Percentage of Participants With 0 (None) or 1 (Minimal) on the GAAS
Time frame: Weeks 2, 6 and 12
Acne Symptom and Impact Scale (ASIS) Sign Domain Score
Time frame: Weeks 2, 6 and 12
ASIS Impact Domain Score
Time frame: Weeks 2, 6 and 12

Results and safety

Results posted to the registry on 19 Aug 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dapsone Gel	68	63

Primary outcome: Change From Baseline in the Global Assessment of Acne Severity (GAAS) Score by Physician

Time frame: Baseline, Week 12. Mean (Standard Deviation). Unit: score on a scale

Measure	Dapsone Gel n = 67
Baseline	2.8 (0.72)
Change from Baseline at Week 12	-1.2 (0.88)

Population analysed: Modified Intent-to treat (mITT) population included all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment.

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dapsone Gel	1 of 68 (1.5%)	0 of 68 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Acne Vulgaris

Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
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RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
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RecruitingPhase 3
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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 Gel 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 3 inclusion and 1 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 19 Aug 2015. 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 19 Aug 2015). 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 the Global Assessment of Acne Severity (GAAS) Score by Physician (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?

On the ClinicalTrials.gov record for NCT02032407.

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 19 Aug 2015.