The Use of Onexton in Moderate Acne Vulgaris for Patients With Skin of Color

Study Overview
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Brief Summary
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This is a single-center, open label pilot study. The study is comprised of 5 study visits; Screening, Baseline, and Weeks 4, 8, and 16. All subjects will receive Onexton at Baseline and be instructed to apply the gel once daily to the face. The investigators will evaluate Investigator Global Assessment of acne (IGA), total lesion count, inflammatory lesion count, non-inflammatory lesion count, Investigator Global Assessment of Post-Inflammatory Hyperpigmentation and distribution of Post-Inflammatory Hyperpigmentation, adverse events and concomitant medications.

Official Title
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The Use of Onexton in Moderate Acne Vulgaris for Patients With Skin of Color

Conditions
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Acne Vulgaris, Post Inflammatory Hyperpigmentation

Intervention / Treatment
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* Drug: ONEXTON Topical Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: i. Outpatient, subjects of skin of color, age 12 or older. Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline and practice a reliable method of contraception throughout the study; A female is considered of childbearing potential unless she is: postmenopausal for at least 12 months prior to study drug administration without a uterus and/or both ovaries; or has been surgically sterile for at least 6 months prior to study drug administration Reliable methods of contraception are: intrauterine device in use ≥ 90 days prior to study drug administration; barrier methods plus spermicide in use at least 14 days prior to study drug administration; or vasectomized partner [Exception: Female subjects of childbearing potential who are not sexually active will not be required to practice a reliable method of contraception. These subjects may be enrolled at the Investigator's discretion if they are counseled to remain sexually inactive during the study and understand the possible risks in getting pregnant during the study.] ii. Facial acne vulgaris in patients with skin of color (Fitzpatrick Type V & VI Supplement VI) characterized by the following: IGA Score for acne vulgaris 3 IGA Score for PIH 3 iii. Able to understand and comply with the requirements of the study and sign Informed Consent /HIPAA Authorization forms Exclusion Criteria: i. Female subjects who are pregnant (positive urine pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control ii. Allergy/sensitivity to any component of the test treatment iii. IGA score for acne of 2 (mild) or 4 (severe) iv. IGA score for Post Inflammatory Hyperpigmentation of 2 (mild) or 4 (severe) v. Subjects who have not complied with the proper wash-out periods for prohibited medications (Supplement I). vi. Medical condition that, in the opinion of the Investigator, contraindicates the subject's participation in the clinical study vii. Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris viii. Evidence of recent alcohol or drug abuse ix. History of poor cooperation, non-compliance with medical treatment, or unreliability x. Exposure to an investigational study drug within 30 days of the Baseline Visit

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single arm Onexton gel application<br>Onexton gel will be supplied to all subjects and applied once daily to the face | Drug: ONEXTON Topical Gel<br>* Onexton gel applied once daily to face<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Global Assessment Scale for Severity of Facial Acne | Percent of subjects achieving clear or almost clear on Investigator's Global Assessment (IGA) scale for facial acne; the IGA scale for acne reflects the Investigator's assessment of the severity of a subject's acne on a scale from 0 to 5 with 0 = Clear Skin, 1 = Almost Clear, 2 = Mild, 3 = Moderate severity, 4 = Severe, 5 = Very Severe Each of these gradations is based upon a lesion count by the Investigator. | Week 4, Week 8, Week 16 | 
| Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation | Percent of subjects achieving clear or almost clear on Investigator's Global Assessment (IGA) scale for severity of post inflammatory hyperpigmentation; the IGA scale of post-inflammatory hyperpigmentation reflects the Investigator's assessment of the severity of a subject's hyperpigmentation on a scale from 0 to 6 with 0 = None, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = moderately Severe, 5 = Severe, 6 = Very severe Each of these gradations is based upon the investigator's impression | Week 4, Week 8, Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Inflammatory Lesions | The Investigator will count the number of facial (from hairline to mandibular line) inflammatory acne lesions at each study visit. Inflammatory lesions include papules, pustules and nodules. | Week 4, Week 8, Week 16 | 
| Percent Change in Non-inflammatory Lesion Count | The Investigator will count the number of facial non-inflammatory acne lesions at each study visit. these include open and closed comedones. | Week 4, Week 8, Week 16 | 
| Percent Change in Total Lesion Count | The Investigator will count the number of facial inflammatory and non-inflammatory acne lesions at each study visit. These include papules, pustules, nodules, and open and closed comedones. | week 4, Week 8, Week 16 | 
| Post-Inflammatory Hyperpigmentation (PIH) Distribution | This measure as assessed by the Investigator seeks to quantify the extent to which post-inflammatory hyperpigmentation is distributed across the face, wherein 0= No PIH, 1=1-10% of the face affected, 2=11-20%, 3=21-30%, 4=31-40%, 5=41-50%, and 6=More than 50% of the face. Lower numbers reflect less severe disease. | baseline, Week 4, week 8, week 16 |