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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Aczone Gel 7.5%
Mount Sinai West
New York, New York, United States
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)
Time frame: baseline and week 12
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. 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Baseline, Week 4, 12, 18, and 24
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