NCT01974323

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,238

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_3

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

February 6, 2017

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

11 months

First QC Date

October 28, 2013

Results QC Date

May 5, 2016

Last Update Submit

October 5, 2018

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (3)

  • 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.

    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).

    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).

    Baseline, Week 12

Secondary Outcomes (6)

  • Change From Baseline in Total Lesion Counts

    Baseline, Week 12

  • Percentage Change From Baseline in Total Lesion Counts

    Baseline, Week 12

  • Percentage of Patients Reporting "Very Good" or "Excellent" on Item 10 of the 5-Point Acne Symptom Impact Scale (ASIS)

    Week 12

  • Change From Baseline in the 9-Item ASIS Sign Domain Score

    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

    Baseline, Week 12

  • +1 more secondary outcomes

Study Arms (2)

Dapsone Gel

EXPERIMENTAL

Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.

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.

Drug: Dapsone Gel Vehicle

Interventions

Dapsone GelDRUG

Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.

Dapsone Gel
Dapsone Gel VehicleDRUG

Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.

Dapsone Gel Vehicle

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Beverly Hills, California, United States

Location

Unknown Facility

Aventura, Florida, United States

Location

Unknown Facility

Windsor, Ontario, Canada

Location

Related Publications (4)

  • 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.

    PMID: 30500141DERIVED

  • 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.

    PMID: 30500140DERIVED

  • 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.

    PMID: 30500139DERIVED

  • 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.

    PMID: 27847545DERIVED

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Results Point of Contact

Title
Therapeutic Area Head,
Organization
Allergan, Inc
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2013

First Posted

November 1, 2013

Study Start

November 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 9, 2018

Results First Posted

February 6, 2017

Record last verified: 2018-10

Locations

US(2)CA(1)