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

NCT03681470 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: GCO 17-2662HSM# 17-01277
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acne Vulgaris

Keywords

skin of color; acne; skin diseases

Outcome Measures

Primary Outcomes (1)

• 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. 1. \- Minimal: Few noninflammatory lesions are present; a few inflammatory lesions (papules/pustules) may be present; no nodulo-cystic lesions present. 2. \- Mild: Several to many noninflammatory lesions are present; a few inflammatory lesions are present; no nodulo-cystic lesions present. 3. \- Moderate: Many noninflammatory and inflammatory lesions are present; no nodulo-cystic lesions are present. 4. \- 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 Outcomes (6)

• Change From Baseline in Global Acne Assessment Score (GAAS) at Week 4, 18 and 24

  baseline and week 4, week 18, and week 24

• Change From Baseline in Post Acne Hyperpigmentation Index (PAHPI) at Weeks 12, 18 and 24

  baseline and week 12, 18, and 24

• Change From Baseline in Melanin Index (MI) of Target Lesion at Weeks 12, 18 and 24

  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

  week 4, 12, 18, and 24

• Number of Subjects With GAAS of 0 (None) or 1 (Minimal) at Weeks 4, 12, 18, 24

  Week 4, 12, 18 and 24

Study Arms (1)

Patients with Acne Vulgaris

EXPERIMENTAL

Acne Vulgaris in Patients With Skin of Color

Drug: Aczone Gel

Interventions

Aczone Gel DRUG

Aczone Gel 7.5%

Also known as: Dapsone

Patients with Acne Vulgaris

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai West

New York, New York, 10023, United States

Location

MeSH Terms

Conditions

Acne Vulgaris; Skin Diseases

Interventions

Dapsone

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals

Results Point of Contact

• Title: Ingrid Sanabria-Gonzalez
• Organization: Icahn School of Medicine at Mount Sinai

ingrid.sanabria@mountsinai.org

212-523-3812

Study Officials

• Saakshi Khattri, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Dermatology

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 24, 2018
• Study Start: April 9, 2019
• Primary Completion: May 6, 2021
• Study Completion: May 6, 2021
• Last Updated: July 27, 2022
• Results First Posted: July 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available upon completion of the study and will remain available until final publication of the data
• Access Criteria: Will only be shared with staff of Allergen directly involved with oversight of clinical study

Locations

US (1)