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

• Sponsor: Icahn School of Medicine at Mount Sinai (Other)
• Overall Status: Completed
• CT.gov ID: NCT03681470
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 24.9
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: Aczone Gel	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Apr 9, 2019
• Actual Primary Completion Date: May 6, 2021
• Actual Study Completion Date: May 6, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Mean Change From Baseline to Week 12 in Global Acne Assessment Score (GAAS) [baseline and week 12]

   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)

Secondary Outcome Measures

1. 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 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)

2. 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 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.

3. Change From Baseline in Melanin Index (MI) of Target Lesion at Weeks 12, 18 and 24 [baseline and week 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.

4. 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]

   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.

5. Number of Subjects With GAAS of 0 (None) or 1 (Minimal) at Weeks 4, 12, 18, 24 [Week 4, 12, 18 and 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.

6. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mount Sinai West	New York	New York	United States	10023

Sponsors and Collaborators

• Icahn School of Medicine at Mount Sinai

Investigators

• Principal Investigator: Saakshi Khattri, MD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 7, 2022

More Information

Publications

None provided.

• Responsible Party: Saakshi Khattri, Assistant Professor, Dermatology, Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT03681470
• Other Study ID Numbers: GCO 17-2662; HSM# 17-01277
• First Posted: Sep 24, 2018
• Last Update Posted: Jul 27, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Saakshi Khattri, Assistant Professor, Dermatology, Icahn School of Medicine at Mount Sinai: skin of color; acne; skin diseases
• Additional relevant MeSH terms: Acne Vulgaris; Dapsone

Study Results

Participant Flow

Arm/Group Title	Patients With Acne Vulgaris
Arm/Group Description	Acne Vulgaris in Patients With Skin of Color Aczone Gel: Aczone Gel 7.5%
Period Title: Overall Study
STARTED	20
COMPLETED	12
NOT COMPLETED	8

Baseline Characteristics

Arm/Group Title	Patients With Acne Vulgaris
Arm/Group Description	Acne Vulgaris in Patients With Skin of Color Aczone Gel: Aczone Gel 7.5%
Overall Participants	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.5 (9.29)
Sex: Female, Male (Count of Participants)
Female	19 95%
Male	1 5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 15%
Not Hispanic or Latino	17 85%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 5%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	16 80%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	3 15%

Outcome Measures

1. Primary Outcome

Title	Mean Change From Baseline to Week 12 in Global Acne Assessment Score (GAAS)
Description	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)
Time Frame	baseline and week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients With Acne Vulgaris
Arm/Group Description	Acne Vulgaris in Patients With Skin of Color Aczone Gel: Aczone Gel 7.5%
Measure Participants	12
Mean (Standard Deviation) [score on a scale]	-0.86 (0.66)

2. Secondary Outcome

Title	Change From Baseline in Global Acne Assessment Score (GAAS) at Week 4, 18 and 24
Description	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)
Time Frame	baseline and week 4, week 18, and week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients With Acne Vulgaris
Arm/Group Description	Acne Vulgaris in Patients With Skin of Color Aczone Gel: Aczone Gel 7.5%
Measure Participants	12
Baseline and Week 4	-0.35 (0.49)
Baseline and Week 18	-1.0 (0.77)
Baseline and Week 24	-1.2 (0.79)

3. Secondary Outcome

Title	Change From Baseline in Post Acne Hyperpigmentation Index (PAHPI) at Weeks 12, 18 and 24
Description	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.
Time Frame	baseline and week 12, 18, and 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients With Acne Vulgaris
Arm/Group Description	Acne Vulgaris in Patients With Skin of Color Aczone Gel: Aczone Gel 7.5%
Measure Participants	12
baseline and week 12	-1.7 (1.77)
baseline and week 18	-2.22 (2.28)
baseline and week 24	-3 (2.58)

4. Secondary Outcome

Title	Change From Baseline in Melanin Index (MI) of Target Lesion at Weeks 12, 18 and 24
Description	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.
Time Frame	baseline and week 12, 18 and 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients With Acne Vulgaris
Arm/Group Description	Acne Vulgaris in Patients With Skin of Color Aczone Gel: Aczone Gel 7.5%
Measure Participants	12
baseline and week12	0.22 (13.94)
baseline and week 18	-2.33 (8.94)
baseline and week 24	-48.5 (77.22)

5. Secondary Outcome

Title	Number of Subjects With Score of 0 or 1 on ASIS "Dark Spot" Score at Weeks 4, 12, 18 and 24
Description	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.
Time Frame	week 4, 12, 18, and 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients With Acne Vulgaris
Arm/Group Description	Acne Vulgaris in Patients With Skin of Color Aczone Gel: Aczone Gel 7.5%
Measure Participants	12
week 4	2 10%
week 12	2 10%
week 18	4 20%
week 24	7 35%

6. Secondary Outcome

Title	Number of Subjects With GAAS of 0 (None) or 1 (Minimal) at Weeks 4, 12, 18, 24
Description	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.
Time Frame	Week 4, 12, 18 and 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients With Acne Vulgaris
Arm/Group Description	Acne Vulgaris in Patients With Skin of Color Aczone Gel: Aczone Gel 7.5%
Measure Participants	12
Week 4	0 0%
Week12	2 10%
Week 18	3 15%
Week 24	4 20%

7. Secondary Outcome

Title	Percent Change From Baseline in All Lesion Counts (Inflammatory, Noninflammatory, and Total) at Weeks 4, 12, 18, and 24
Time Frame	Baseline, Week 4, 12, 18, and 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients With Acne Vulgaris
Arm/Group Description	Acne Vulgaris in Patients With Skin of Color Aczone Gel: Aczone Gel 7.5%
Measure Participants	12
Baseline and week 4	-29 (19)
Baseline and week 12	-46 (24)
Baseline and week 18	-55 (23)
Baseline and week 24	-53 (31)

Adverse Events

Time Frame	24 weeks
Arm/Group Title	Patients With Acne Vulgaris
Arm/Group Description	Acne Vulgaris in Patients With Skin of Color Aczone Gel: Aczone Gel 7.5%
All Cause Mortality
	Patients With Acne Vulgaris
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Serious Adverse Events
	Patients With Acne Vulgaris
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	Patients With Acne Vulgaris
	Affected / at Risk (%)	# Events
Total	16/20 (80%)
General disorders
Vocal cord fatigue	1/20 (5%)
Right hand burn	1/20 (5%)
left hand burn	1/20 (5%)
Infections and infestations
Upper respiratory infection	2/20 (10%)
Common cold	1/20 (5%)
COVID-19	1/20 (5%)
Nervous system disorders
Syncope	1/20 (5%)
Psychiatric disorders
Insomnia	1/20 (5%)
Renal and urinary disorders
Urinary tract infection	1/20 (5%)
Skin and subcutaneous tissue disorders
Dry patches of skin	1/20 (5%)
Traction alopecia	1/20 (5%)
Pityriasis rosea	1/20 (5%)
Post inflammatory hyperpigmentation	1/20 (5%)
Worsening post inflammatory hyperpigmentation	1/20 (5%)
Rough facial skin	1/20 (5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.