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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01974141

Enrollment

2102

Registered

2013-11-01

Start date

2013-11-30

Completion date

2014-10-31

Last updated

2018-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

Brief summary

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

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.

Interventions

DRUGDapsone Gel

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

DRUGDapsone Gel Vehicle

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Patients With a Score of 0 (None) or 1 (Minimal) on the 5-point Global Acne Assessment Score (GAAS)	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	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	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).

Secondary

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

Countries

Canada, United States

Participant flow

Pre-assignment details

The Intent-to-Treat population is reflected in the overall study properties. This population excludes patients from a site with Good Clinical Practice violations. All data from this site are excluded in the study results.

Participants by arm

Arm	Count
Dapsone Gel Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.	1,044
Dapsone Gel Vehicle Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.	1,058
Total	2,102

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	4	5
Overall Study	Lack of Efficacy	0	1
Overall Study	Lost to Follow-up	38	29
Overall Study	Other Reasons	28	18
Overall Study	Personal Reasons	21	20
Overall Study	Pregnancy	3	3
Overall Study	Protocol Violation	2	6

Baseline characteristics

Characteristic	Dapsone Gel	Dapsone Gel Vehicle	Total
Age, Continuous	20.0 Years STANDARD_DEVIATION 7.41	20.0 Years STANDARD_DEVIATION 7.53	20.0 Years STANDARD_DEVIATION 7.47
Sex: Female, Male Female	591 Participants	582 Participants	1173 Participants
Sex: Female, Male Male	453 Participants	476 Participants	929 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 1,044	0 / 1,057
serious Total, serious adverse events	3 / 1,044	5 / 1,057

Outcome results

Primary

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).

Time frame: Baseline, Week 12