Trial Outcomes & Findings for Aczone Gel 7.5% in the Treatment of Acne Vulgaris in Patients With Skin of Color (NCT NCT03681470)

Last Updated: 2022-07-27

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

baseline and week 12

Results posted on

2022-07-27

Participant Flow

Participant milestones

Participant milestones
Measure	Patients With Acne Vulgaris Acne Vulgaris in Patients With Skin of Color Aczone Gel: Aczone Gel 7.5%
Overall Study STARTED	20
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients With Acne Vulgaris Acne Vulgaris in Patients With Skin of Color Aczone Gel: Aczone Gel 7.5%
Overall Study Lack of Efficacy	3
Overall Study Lost to Follow-up	1
Overall Study Protocol Violation	3
Overall Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Acne Vulgaris n=20 Participants Acne Vulgaris in Patients With Skin of Color Aczone Gel: Aczone Gel 7.5%
Age, Continuous	29.5 years STANDARD_DEVIATION 9.29 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and week 12

Outcome measures

Outcome measures
Measure	Patients With Acne Vulgaris n=12 Participants Acne Vulgaris in Patients With Skin of Color Aczone Gel: Aczone Gel 7.5%
Mean Change From Baseline to Week 12 in Global Acne Assessment Score (GAAS)	-0.86 score on a scale Standard Deviation 0.66

SECONDARY outcome

Timeframe: 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. 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)

Outcome measures

Outcome measures
Measure	Patients With Acne Vulgaris n=12 Participants Acne Vulgaris in Patients With Skin of Color Aczone Gel: Aczone Gel 7.5%
Change From Baseline in Global Acne Assessment Score (GAAS) at Week 4, 18 and 24 Baseline and Week 4	-0.35 score on a scale Standard Deviation 0.49
Change From Baseline in Global Acne Assessment Score (GAAS) at Week 4, 18 and 24 Baseline and Week 18	-1.0 score on a scale Standard Deviation 0.77
Change From Baseline in Global Acne Assessment Score (GAAS) at Week 4, 18 and 24 Baseline and Week 24	-1.2 score on a scale Standard Deviation 0.79

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With Acne Vulgaris n=12 Participants Acne Vulgaris in Patients With Skin of Color Aczone Gel: Aczone Gel 7.5%
Change From Baseline in Post Acne Hyperpigmentation Index (PAHPI) at Weeks 12, 18 and 24 baseline and week 12	-1.7 score on a scale Standard Deviation 1.77
Change From Baseline in Post Acne Hyperpigmentation Index (PAHPI) at Weeks 12, 18 and 24 baseline and week 18	-2.22 score on a scale Standard Deviation 2.28
Change From Baseline in Post Acne Hyperpigmentation Index (PAHPI) at Weeks 12, 18 and 24 baseline and week 24	-3 score on a scale Standard Deviation 2.58

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With Acne Vulgaris n=12 Participants Acne Vulgaris in Patients With Skin of Color Aczone Gel: Aczone Gel 7.5%
Change From Baseline in Melanin Index (MI) of Target Lesion at Weeks 12, 18 and 24 baseline and week12	0.22 Melanin Index (M) Standard Deviation 13.94
Change From Baseline in Melanin Index (MI) of Target Lesion at Weeks 12, 18 and 24 baseline and week 18	-2.33 Melanin Index (M) Standard Deviation 8.94
Change From Baseline in Melanin Index (MI) of Target Lesion at Weeks 12, 18 and 24 baseline and week 24	-48.5 Melanin Index (M) Standard Deviation 77.22

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With Acne Vulgaris n=12 Participants Acne Vulgaris in Patients With Skin of Color Aczone Gel: Aczone Gel 7.5%
Number of Subjects With Score of 0 or 1 on ASIS "Dark Spot" Score at Weeks 4, 12, 18 and 24 week 4	2 Participants
Number of Subjects With Score of 0 or 1 on ASIS "Dark Spot" Score at Weeks 4, 12, 18 and 24 week 12	2 Participants
Number of Subjects With Score of 0 or 1 on ASIS "Dark Spot" Score at Weeks 4, 12, 18 and 24 week 18	4 Participants
Number of Subjects With Score of 0 or 1 on ASIS "Dark Spot" Score at Weeks 4, 12, 18 and 24 week 24	7 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With Acne Vulgaris n=12 Participants Acne Vulgaris in Patients With Skin of Color Aczone Gel: Aczone Gel 7.5%
Number of Subjects With GAAS of 0 (None) or 1 (Minimal) at Weeks 4, 12, 18, 24 Week 4	0 Participants
Number of Subjects With GAAS of 0 (None) or 1 (Minimal) at Weeks 4, 12, 18, 24 Week12	2 Participants
Number of Subjects With GAAS of 0 (None) or 1 (Minimal) at Weeks 4, 12, 18, 24 Week 18	3 Participants
Number of Subjects With GAAS of 0 (None) or 1 (Minimal) at Weeks 4, 12, 18, 24 Week 24	4 Participants

SECONDARY outcome

Timeframe: Baseline, Week 4, 12, 18, and 24

Outcome measures

Outcome measures
Measure	Patients With Acne Vulgaris n=12 Participants Acne Vulgaris in Patients With Skin of Color Aczone Gel: Aczone Gel 7.5%
Percent Change From Baseline in All Lesion Counts (Inflammatory, Noninflammatory, and Total) at Weeks 4, 12, 18, and 24 Baseline and week 4	-29 percent change Standard Deviation 19
Percent Change From Baseline in All Lesion Counts (Inflammatory, Noninflammatory, and Total) at Weeks 4, 12, 18, and 24 Baseline and week 12	-46 percent change Standard Deviation 24
Percent Change From Baseline in All Lesion Counts (Inflammatory, Noninflammatory, and Total) at Weeks 4, 12, 18, and 24 Baseline and week 18	-55 percent change Standard Deviation 23
Percent Change From Baseline in All Lesion Counts (Inflammatory, Noninflammatory, and Total) at Weeks 4, 12, 18, and 24 Baseline and week 24	-53 percent change Standard Deviation 31

Adverse Events

Patients With Acne Vulgaris

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Patients With Acne Vulgaris n=20 participants at risk Acne Vulgaris in Patients With Skin of Color Aczone Gel: Aczone Gel 7.5%
Skin and subcutaneous tissue disorders Dry patches of skin	5.0% 1/20 • 24 weeks
Skin and subcutaneous tissue disorders Traction alopecia	5.0% 1/20 • 24 weeks
Psychiatric disorders Insomnia	5.0% 1/20 • 24 weeks
Infections and infestations Upper respiratory infection	10.0% 2/20 • 24 weeks
Nervous system disorders Syncope	5.0% 1/20 • 24 weeks
Renal and urinary disorders Urinary tract infection	5.0% 1/20 • 24 weeks
General disorders Vocal cord fatigue	5.0% 1/20 • 24 weeks
Skin and subcutaneous tissue disorders Pityriasis rosea	5.0% 1/20 • 24 weeks
Infections and infestations Common cold	5.0% 1/20 • 24 weeks
Skin and subcutaneous tissue disorders Post inflammatory hyperpigmentation	5.0% 1/20 • 24 weeks
Skin and subcutaneous tissue disorders Worsening post inflammatory hyperpigmentation	5.0% 1/20 • 24 weeks
Skin and subcutaneous tissue disorders Rough facial skin	5.0% 1/20 • 24 weeks
General disorders Right hand burn	5.0% 1/20 • 24 weeks
Infections and infestations COVID-19	5.0% 1/20 • 24 weeks
General disorders left hand burn	5.0% 1/20 • 24 weeks

Additional Information

Ingrid Sanabria-Gonzalez

Icahn School of Medicine at Mount Sinai

Phone: 212-523-3812

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60