Acne VulgarisPhase 3NCT01974323

Safety and Efficacy Study of Dapsone Gel in Patients With Acne Vulgaris

A Phase 3 study testing Dapsone Gel in people with Acne Vulgaris, run by Almirall, S.A. at 3 sites in 2 countries.

Completed

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

Trial summary

This study will assess the safety and efficacy of dapsone gel versus vehicle control in patients with 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 Gel
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 2,238 participants
Where: 3 sitesin 2 countries
Study dates: Nov 2013to Oct 2014
Phase: Phase 3
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

Diagnosis of acne vulgaris
Willing to avoid excessive or prolonged exposure to ultraviolet light (eg, sunlight, tanning beds) throughout the study

Who cannot join

Severe cystic acne, acne conglobata, acne fulminans, or secondary acne
Use of phototherapy devices (eg, ClearLight™), energy-based devices, adhesive cleansing strips (eg, Pond's®, Biore®), or cosmetic procedures (eg, facials, peeling, comedo extraction) in the past week
Use of anti-inflammatory medications, salicylic acid; corticosteroids, antibiotics, antibacterials (including benzoyl peroxide-containing products [eg, benzamycin]), retinoids; other topical acne treatments (eg, photodynamic therapy, medicated soaps such as those containing benzoyl peroxide, salicylic acid, sulfur, or sodium sulfacetamide) in the past 2 weeks
Use of birth control pills strictly for acne control

Trial locations and contacts

3 sites in 2 countries.

Country

City, postcode or hospital

3 sites in 2 countries

United States2 sites

Study site
Aventura, Florida
Study site
Beverly Hills, California

Other trials in United States

Canada1 site

Study site
Windsor, Ontario

Other trials in Canada

About this study

Official title: A Safety and Efficacy Study to Compare Dapsone Dermal Gel With Vehicle Control in Patients With Acne Vulgaris

This study will assess the safety and efficacy of dapsone gel versus vehicle control in patients with acne vulgaris.

Read the detailed description

This is a multicenter, double-blind, randomized, parallel-group, vehicle-controlled study to assess the safety and efficacy of dapsone 7.5% gel versus vehicle administered topically once daily for 12 weeks in patients with acne vulgaris.

Conditions: Acne Vulgaris
Being tested: Dapsone Gel, Dapsone Gel Vehicle
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
Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
Dapsone Gel VehicleDrug
Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.

Study groups in NCT01974323
Study group	Role	What they receive
Dapsone Gel	Experimental	Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks. Receives: Drug: Dapsone Gel
Dapsone Gel Vehicle	Placebo comparator	Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks. Receives: Drug: Dapsone Gel Vehicle

What is being measured

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

Percentage of Patients With a Score of 0 (None) or 1 (Minimal) on the 5-point Global Acne Assessment Score (GAAS)
The Investigator evaluated the patient's acne severity using the 5-point GAAS scale with 0 being none and 4 being severe. The complete scale is as follow: Grade 0 (none) = No evidence of facila acne vulgaris; Grade 1 (minimal) = Few noninflammatory lesions (comedones) are present, a few inflammatory lesions (papules/pustules) may be present, no nodulo-cyctic lesions are allowed; Grade 2 (mild) = Several to many noninflammatory lesions (comedones) are present, a few inflammatory lesions (papules/pustules) are present, no nodulo-cystic lesions are allowed; Grade 3 (moderate) = Many noninflammatory (comedones) and inflammatory lesions (papules/pustules) are present, no nodulo-cystic lesions are allowed; Grade 4 (severe) = Significant degree of inflammatory disease, papules/pustules are a predominant feature, a few nodulo-cystic lesions may be present, comedones may be present.
Measured: Week 12
Change From Baseline in Inflammatory Facial Lesion Counts
The Investigator evaluated the patient's inflammatory lesions (papule, pustule and nodule/cyst). A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).
Measured: Baseline, Week 12
Change From Baseline in Noninflammatory Facial Lesion Counts
The Investigator evaluated the patient's noninflammatory lesions (papule, pustule and nodule/cyst). A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).
Measured: Baseline, Week 12

Secondary outcomes (6)

Change From Baseline in Total Lesion Counts
The Investigator evaluated the patient's 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 change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).
Measured: Baseline, Week 12
Percentage Change From Baseline in Total Lesion Counts
The Investigator evaluated the patient's 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) and a positive percent change from baseline indicates an increase in lesion counts (worsening).
Measured: Baseline, Week 12
Percentage of Patients Reporting "Very Good" or "Excellent" on Item 10 of the 5-Point Acne Symptom Impact Scale (ASIS)
The patient assessed the impact of their acne vulgaris on the look of their face using item 10 on the 5-point ASIS. Item 10 scores range from 1 (Excellent) to 5 (Bad). The percentage of patients who had an ASIS score of 4 (Fair) or 5 (Bad) at baseline and who reported "Very good" or "Excellent" at Week 12 are reported.
Measured: Week 12
Change From Baseline in the 9-Item ASIS Sign Domain Score
The patient 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 assessed 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. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Measured: Baseline, Week 12
Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Oiliness on a the 5-Point ASIS Scale
The patient assessed their facial oiliness using item 1 on the 5-point ASIS. Item 1 scores ranged from 0 (Not at all oily) to 4 (Very oily). The percentage of patients who reported at least a 1-grade improvement from baseline in their facial oiliness are reported.
Measured: Baseline, Week 12
Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Redness on a the 5-Point ASIS Scale
The patient assessed their facial redness using item 8 on the 5-point ASIS. Item 8 scores ranged from 0 (Not at all red) to 4 (Very red). The percentage of patients who reported at least a 1-grade improvement from baseline in their facial redness are reported.
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.

Nov 2013Oct 2014

First posted1 Nov 2013 (estimated)
Study startNov 2013
Primary completionOct 2014
Study completionOct 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.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Acne VulgarisStudies of the same condition, open and under way.
More trials run by Almirall, S.A.The sponsor's other registered studies.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 2,238 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01974323
Sponsor's protocol ID: 225678-007
Status last verified: Oct 2018
First submitted: 28 Oct 2013
Last updated: 9 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Tanghetti E, Harper J, Baldwin H, Kircik L, Bai Z, Alvandi N. Once-Daily Topical Dapsone Gel, 7.5%: Effective for Acne Vulgaris Regardless of Baseline Lesion Count, With Superior Efficacy in Females. J Drugs Dermatol. 2018 Nov 1;17(11):1192-1198.
PubMed 30500141
Tanghetti E, Harper J, Baldwin H, Kircik L, Bai Z, Alvandi N. Once-Daily Topical Dapsone Gel, 7.5%: Effective for Acne Vulgaris Regardless of Baseline Lesion Count, With Superior Efficacy in Females. J Drugs Dermatol. 2018 Nov 1;17(11):1192-1198.
PubMed 30500140
Tanghetti E, Harper J, Baldwin H, Kircik L, Bai Z, Alvandi N. Once-Daily Topical Dapsone Gel, 7.5%: Effective for Acne Vulgaris Regardless of Baseline Lesion Count, With Superior Efficacy in Females. J Drugs Dermatol. 2018 Nov 1;17(11):1192-1198.
PubMed 30500139
Thiboutot DM, Kircik L, McMichael A, Cook-Bolden FE, Tyring SK, Berk DR, Chang-Lin JE, Lin V, Kaoukhov A. Efficacy, Safety, and Dermal Tolerability of Dapsone Gel, 7.5% in Patients with Moderate Acne Vulgaris: A Pooled Analysis of Two Phase 3 Trials. J Clin Aesthet Dermatol. 2016 Oct;9(10):18-27. Epub 2016 Oct 1.
PubMed 27847545

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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All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Safety and Efficacy Study to Compare Dapsone Dermal Gel With Vehicle Control in Patients With Acne Vulgaris
ClinicalTrials.gov ID: NCT01974323
Acronym / sponsor ID: 225678-007
Conditions: Acne Vulgaris
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,238 participants (actual)
Lead sponsor: Almirall, S.A.Industry (pharma, biotech, devices)
Collaborators: Allergan
Study start: Nov 2013
Primary completion: Oct 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 1 Nov 2013 (estimated)
Results: Posted 6 Feb 2017

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 assess the safety and efficacy of dapsone gel versus vehicle control in patients with acne vulgaris.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Dapsone Gel	Experimental	Drug: Dapsone GelDapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
Dapsone Gel Vehicle	Placebo comparator	Drug: Dapsone Gel VehicleDapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Diagnosis of acne vulgaris
Willing to avoid excessive or prolonged exposure to ultraviolet light (eg, sunlight, tanning beds) throughout the study

Key exclusion criteria (4 listed)

Severe cystic acne, acne conglobata, acne fulminans, or secondary acne
Use of phototherapy devices (eg, ClearLight™), energy-based devices, adhesive cleansing strips (eg, Pond's®, Biore®), or cosmetic procedures (eg, facials, peeling, comedo extraction) in the past week
Use of anti-inflammatory medications, salicylic acid; corticosteroids, antibiotics, antibacterials (including benzoyl peroxide-containing products [eg, benzamycin]), retinoids; other topical acne treatments (eg, photodynamic therapy, medicated soaps such as those containing benzoyl peroxide, salicylic acid, sulfur, or sodium sulfacetamide) in the past 2 weeks
Use of birth control pills strictly for acne control

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 GelDapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.	Drug	Dapsone Gel
Dapsone Gel VehicleDapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.	Drug	Dapsone Gel Vehicle

Primary outcome

Percentage of Patients With a Score of 0 (None) or 1 (Minimal) on the 5-point Global Acne Assessment Score (GAAS)
Time frame: Week 12
The Investigator evaluated the patient's acne severity using the 5-point GAAS scale with 0 being none and 4 being severe. The complete scale is as follow: Grade 0 (none) = No evidence of facila acne vulgaris; Grade 1 (minimal) = Few noninflammatory lesions (comedones) are present, a few inflammatory lesions (papules/pustules) may be present, no nodulo-cyctic lesions are allowed; Grade 2 (mild) = Several to many noninflammatory lesions (comedones) are present, a few inflammatory lesions (papules/pustules) are present, no nodulo-cystic lesions are allowed; Grade 3 (moderate) = Many noninflammatory (comedones) and inflammatory lesions (papules/pustules) are present, no nodulo-cystic lesions are allowed; Grade 4 (severe) = Significant degree of inflammatory disease, papules/pustules are a predominant feature, a few nodulo-cystic lesions may be present, comedones may be present.
Change From Baseline in Inflammatory Facial Lesion Counts
Time frame: Baseline, Week 12
The Investigator evaluated the patient's inflammatory lesions (papule, pustule and nodule/cyst). A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).
Change From Baseline in Noninflammatory Facial Lesion Counts
Time frame: Baseline, Week 12
The Investigator evaluated the patient's noninflammatory lesions (papule, pustule and nodule/cyst). A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).

6 secondary outcomes

Change From Baseline in Total Lesion Counts
Time frame: Baseline, Week 12
Percentage Change From Baseline in Total Lesion Counts
Time frame: Baseline, Week 12
Percentage of Patients Reporting "Very Good" or "Excellent" on Item 10 of the 5-Point Acne Symptom Impact Scale (ASIS)
Time frame: Week 12
Change From Baseline in the 9-Item ASIS Sign Domain Score
Time frame: Baseline, Week 12
Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Oiliness on a the 5-Point ASIS Scale
Time frame: Baseline, Week 12
Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Redness on a the 5-Point ASIS Scale
Time frame: Baseline, Week 12

Results and safety

Results posted to the registry on 6 Feb 2017, 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	1,118	1,026
Dapsone Gel Vehicle	1,120	1,027

Primary outcome: Percentage of Patients With a Score of 0 (None) or 1 (Minimal) on the 5-point Global Acne Assessment Score (GAAS)

Time frame: Week 12. Number. Unit: Percentage of Patients

Measure	Dapsone Gel n = 1118	Dapsone Gel Vehicle n = 1120
Value	29.8	20.9

Population analysed: Intent-to-Treat: all randomized patients

Primary outcome: Change From Baseline in Inflammatory Facial Lesion Counts

Time frame: Baseline, Week 12. Mean (Standard Error). Unit: Number of Inflammatory Lesions

Measure	Dapsone Gel n = 1118	Dapsone Gel Vehicle n = 1120
Baseline	29.6 (0.23)	30.0 (0.23)
Change from Baseline at Week 12	-15.6 (0.35)	-14.0 (0.35)

Population analysed: Intent-to-Treat: all randomized patients

Primary outcome: Change From Baseline in Noninflammatory Facial Lesion Counts

Time frame: Baseline, Week 12. Mean (Standard Error). Unit: Number of Noninflammatory Lesions

Measure	Dapsone Gel n = 1118	Dapsone Gel Vehicle n = 1120
Baseline	46.7 (0.46)	46.7 (0.46)
Change from Baseline at Week 12	-20.8 (0.55)	-18.7 (0.55)

Population analysed: Intent-to-Treat: all randomized patients

6 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	4 of 1,117 (0.4%)	0 of 1,117 (0%)	Not reported
Dapsone Gel Vehicle	4 of 1,118 (0.4%)	0 of 1,118 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30500141Tanghetti E, Harper J, Baldwin H, Kircik L, Bai Z, Alvandi N. Once-Daily Topical Dapsone Gel, 7.5%: Effective for Acne Vulgaris Regardless of Baseline Lesion Count, With Superior Efficacy in Females. J Drugs Dermatol. 2018 Nov 1;17(11):1192-1198.
Derived from this study: PubMed 30500140Tanghetti E, Harper J, Baldwin H, Kircik L, Bai Z, Alvandi N. Once-Daily Topical Dapsone Gel, 7.5%: Effective for Acne Vulgaris Regardless of Baseline Lesion Count, With Superior Efficacy in Females. J Drugs Dermatol. 2018 Nov 1;17(11):1192-1198.
Derived from this study: PubMed 30500139Tanghetti E, Harper J, Baldwin H, Kircik L, Bai Z, Alvandi N. Once-Daily Topical Dapsone Gel, 7.5%: Effective for Acne Vulgaris Regardless of Baseline Lesion Count, With Superior Efficacy in Females. J Drugs Dermatol. 2018 Nov 1;17(11):1192-1198.
Derived from this study: PubMed 27847545Thiboutot DM, Kircik L, McMichael A, Cook-Bolden FE, Tyring SK, Berk DR, Chang-Lin JE, Lin V, Kaoukhov A. Efficacy, Safety, and Dermal Tolerability of Dapsone Gel, 7.5% in Patients with Moderate Acne Vulgaris: A Pooled Analysis of Two Phase 3 Trials. J Clin Aesthet Dermatol. 2016 Oct;9(10):18-27. Epub 2016 Oct 1.

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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

3 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dapsone Gel in people with Acne Vulgaris, run by Almirall, S.A. 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 2 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 9 Oct 2018. 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 States, Canada. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 6 Feb 2017). 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 Patients With a Score of 0 (None) or 1 (Minimal) on the 5-point Global Acne Assessment Score (GAAS) (time frame: Week 12). The study lists 3 primary outcomes in all. 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 NCT01974323, which also lists 4 linked publications.

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 9 Oct 2018.