Aczone Gel 7.5% in the Treatment of Acne Vulgaris in Patients With Skin of Color

An Open-label Study to Investigate the Efficacy and Tolerability of Aczone Gel, 7.5% in the Treatment of Acne Vulgaris in Men and Women With Skin of Color

Acne vulgaris is a common skin disease characterized by inflammatory papules, pustules, and comedones that is prevalent in men and women of color. Research has demonstrated that Aczone ® (dapsone) gel, 7.5% used once daily is effective, safe, and well-tolerated for the treatment of acne in both men and women; however, limited data is available regarding its efficacy and safety in skin of color (SOC). The current study aims to investigate the therapeutic impact of Aczone gel 7.5% in SOC males and females ages 18 and older with acne vulgaris. The study will also evaluate the impact of Aczone ® gel on hyperpigmentation and PIH of the face.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Aczone Gel

Detailed Description

Acne vulgaris is a common skin disease characterized by inflammatory papules, pustules, and comedones that is prevalent in men and women of color. In fact, acne is the most common dermatologic diagnosis made in SOC populations. Although individuals of all skin types can develop acne vulgaris, there are important differences in darker skin types that are important to consider when choosing an optimal treatment.

Complications from acne are of great concern in this population, as keloids, hypertrophic scars, and post-inflammatory hyperpigmentation (PIH) are more common in skin of color. PIH may last for weeks to months and, in many cases, is more troublesome to patients than the acne itself. Overall, facial acne and its sequelae have a greater impact on perception of appearance, negative emotions, and social functioning in women of color than white women.

Dapsone is a sulfone compound with anti-inflammatory properties that has been shown to be effective in the treatment of acne vulgaris in SOC. Aczone ® (dapsone) gel, 5% administered twice daily has been associated with significant improvement in overall acne severity, acne signs, and impact on quality of life in women of color. Two phase III trials of a newer formulation of Aczone ® (dapsone) gel, 7.5% used once daily demonstrated that this product is effective, safe, and well-tolerated for the treatment of acne in both men and women; however, limited data is available regarding its efficacy and safety in SOC.

Further, some investigators of the phase IV study on the safety and efficacy of dapsone gel 5% in SOC anecdotally reported improvement in hyperpigmentation over 12 weeks, although this was not a planned efficacy outcome. Further research is needed on the potential effects of dapsone gel on hyperpigmentation and PIH in SOC.

The current study will investigate the therapeutic impact of Aczone gel 7.5% in SOC males and females ages 18 and older with acne vulgaris. The study will also evaluate the impact of Aczone gel on post-inflammatory hyperpigmentation using the Postacne Hyperpigmentation Index (PAHPI) and mexameter-measured melanin index (MI).

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10023
      • Mount Sinai West

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Provide written, signed and dated informed consent prior to initiating any study-related activities.
• Male or female subjects who are ≥ 18 years of age
• Subjects with Fitzpatrick Skin Type IV, V, or VI
• Subjects with moderate to severe acne as defined by investigator- assessed Global Acne Assessment Score (GAAS) of 3 or 4 at screening
• Facial acne vulgaris with 20 to 50 (inclusive) inflammatory lesions and 30 to 100 (inclusive)non inflammatory lesion
• Stable non-progressive or regressive acne vulgaris in the investigator's opinion
• Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. A female is considered not to be of childbearing potential if she is post-menopausal with at least 12 consecutive months of amenorrhea or has undergone surgical sterilization. While on investigational product and for at least 28 days after taking the last dose of investigational product, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below:

Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]; PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.

• Must be in general good as judged by the Investigator
• Subject is willing to avoid excessive or prolonged exposure of the treated skin to ultraviolet light (i.e. sunlight, tanning beds) throughout the study
• Subject is willing to follow study instructions and complete study assessments without assistance and is likely to complete all required visits

Exclusion Criteria:

• Diagnosis of other dermatologic diagnosis that, in the opinion of the investigator, would interfere with diagnosis, examination, or treatment of the studied condition (i.e. psoriasis, atopic dermatitis, lupus, dermatomyositis, seborrheic dermatitis, perioral dermatitis, etc.)
• Subjects with severe cystic acne, acne conglobate, acne fulminans, or secondary acne (chloracne or drug-induced acne)
• Uncontrolled systemic disease(s) that, in the opinion of the investigator, would put the patient at significant risk if enrolled in the study or would interfere with subject's participation in the study
• Subjects with a history of clinically significant hemolysis, anemia, or enteritis (regional enteritis, ulcerative colitis, pseudomembranous colitis, antibiotic-associated colitis)
• Subjects with allergy or sensitivity to the study drug or its components

• Subjects who have not complied with the proper wash-out periods:

  • Topical anti-inflammatory medications, salicylic acid, corticosteroids, antibiotics, antibacterials, peroxide-containing products, or retinoids within 2 weeks of baseline
  • Systemic antibiotics, corticosteroids, antimalarials or oral dapsone within 4 weeks of baseline Other anti-acne medication, including isotretinoin or spironolactone, within 6 months of baseline
  • Chemical peels or other facial acne procedures (laser therapy, light therapy) within 3 months of baseline
  • Treatment with botulinum toxin of any serotype in the face within 6 months of baseline
  • Estrogens/Birth control pills must have been started ≥ 90 days prior to baseline and use must be continued during the study without alteration or discontinuation.
  • Pregnant or breast feeding.
  • Subjects with evidence of alcohol or substance abuse.
  • Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Patients with Acne Vulgaris; Acne Vulgaris in Patients With Skin of Color	Drug: Aczone Gel; Aczone Gel 7.5%; Other Names: Dapsone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline to Week 12 in Global Acne Assessment Score (GAAS)	GAAS assesses acne severity on a 5-point score: 0 - None: No evidence of facial acne vulgaris.; - Minimal: Few noninflammatory lesions are present; a few inflammatory lesions (papules/pustules) may be present; no nodulo-cystic lesions present.; - Mild: Several to many noninflammatory lesions are present; a few inflammatory lesions are present; no nodulo-cystic lesions present.; - Moderate: Many noninflammatory and inflammatory lesions are present; no nodulo-cystic lesions are present.; - Severe: Significant degree of inflammatory disease; papules and pustules are a predominant feature; a few nodulo-cystic lesions are present (no more than 2)	baseline and week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Global Acne Assessment Score (GAAS) at Week 4, 18 and 24	Change from baseline at week 4, week 18 and week 24. GAAS assesses acne severity on a 5-point score: 0 - None: No evidence of facial acne vulgaris.; - Minimal: Few noninflammatory lesions are present; a few inflammatory lesions (papules/pustules) may be present; no nodulo-cystic lesions present.; - Mild: Several to many noninflammatory lesions are present; a few inflammatory lesions are present; no nodulo-cystic lesions present.; - Moderate: Many noninflammatory and inflammatory lesions are present; no nodulo-cystic lesions are present.; - Severe: Significant degree of inflammatory disease; papules and pustules are a predominant feature; a few nodulo-cystic lesions are present (no more than 2)	baseline and week 4, week 18, and week 24
Change From Baseline in Post Acne Hyperpigmentation Index (PAHPI) at Weeks 12, 18 and 24	Change from baseline at weeks 12, 18, and 24. PAHPI will be scored using the following formula: Weighted Total PAHPI = S (lesion size) + I (lesion intensity) + N (lesion number). Total PAHPI Score can range from 6-22, with higher number indicating more pigmentation.	baseline and week 12, 18, and 24
Change From Baseline in Melanin Index (MI) of Target Lesion at Weeks 12, 18 and 24	A narrowband reflectance spectrophotometer (mexameter MX-16) will be used to measure the degree of pigmentation of involved and adjacent uninvolved skin of one representation facial PIH lesion. The mexameter contains 16 light emitting diodes arranged circularly that emit light at wavelengths of 568nm (green), 660nm (red), and 880nm (near infrared). The machine then measures the amount of light absorbed and reflected by the skin to measure the melanin content (melanin index or "M" - red and near infrared light). There is no minimum or maximum to this index. Higher melanin index indicates more melanin content in the skin. Higher or increase MI indicates poorer health outcomes.	baseline and week 12, 18 and 24
Number of Subjects With Score of 0 or 1 on ASIS "Dark Spot" Score at Weeks 4, 12, 18 and 24	The participant assesses signs of acne vulgaris using the Acne Symptom and Impact Scale (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). Total possible score of 0 to 68. Higher scores indicate the presence of more severe symptoms and poorer outcomes on acne health-related quality of life.	week 4, 12, 18, and 24
Number of Subjects With GAAS of 0 (None) or 1 (Minimal) at Weeks 4, 12, 18, 24	The change in the proportion of subjects with GAAS scores equal to 0 (or 1) from baseline. GAAS assesses acne severity: 0 - None: No evidence of facial acne vulgaris. 1 - Minimal: Few noninflammatory lesions are present; a few inflammatory lesions (papules/pustules) may be present; no nodulo-cystic lesions present.	Week 4, 12, 18 and 24
Percent Change From Baseline in All Lesion Counts (Inflammatory, Noninflammatory, and Total) at Weeks 4, 12, 18, and 24		Baseline, Week 4, 12, 18, and 24

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 9, 2019
• Primary Completion (ACTUAL): May 6, 2021
• Study Completion (ACTUAL): May 6, 2021

Study Registration Dates

• First Submitted: September 20, 2018
• First Submitted That Met QC Criteria: September 20, 2018
• First Posted (ACTUAL): September 24, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 4, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: skin diseases; acne; skin of color
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Leprostatic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Folic Acid Antagonists; Dapsone
• Other Study ID Numbers: GCO 17-2662; HSM# 17-01277 (OTHER: Icahn School of Medicine at Mount Sinai)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IDP will be shared with Allergan
• IPD Sharing Time Frame: Data will become available upon completion of the study and will remain available until final publication of the data
• IPD Sharing Access Criteria: Will only be shared with staff of Allergen directly involved with oversight of clinical study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No