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Topical Acne Medication
The Use of Onexton in Moderate Acne Vulgaris for Patients With Skin of Color
Phase 4
Waitlist Available
Research Sponsored by Derm Research, PLLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4, week 8, week 16
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved
All Individual Drugs Already Approved
Summary
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.
Eligible Conditions
- Acne Vulgaris
- Postinflammatory Hyperpigmentation
- Acne
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 4, week 8, week 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4, week 8, week 16
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Investigator Global Assessment Scale for Severity of Facial Acne
Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation
Secondary study objectives
Percent Change in Inflammatory Lesions
Percent Change in Non-inflammatory Lesion Count
Percent Change in Total Lesion Count
+1 moreSide effects data
From 2018 Phase 4 trial • 21 Patients • NCT0340289315%
rhinorrhea
10%
pharyngitis
10%
headache
10%
upper respiratory infection
5%
bronchitis
5%
group A beta hemolytic strep pharyngitis
5%
maxillary fracture
5%
intermittent mid back pain
5%
cellulitis right knee
5%
pneumonia
5%
unexpected menses
5%
bacterial vaginosis
5%
serous otitis media
5%
facial tattoo tightening
5%
cough
5%
chest soreness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Onexton Gel Application
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
1Treatment groups
Experimental Treatment
Group I: single arm Onexton gel applicationExperimental Treatment1 Intervention
Onexton gel will be supplied to all subjects and applied once daily to the face
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clindamycin
FDA approved
Find a Location
Who is running the clinical trial?
Derm Research, PLLCLead Sponsor
17 Previous Clinical Trials
551 Total Patients Enrolled
4 Trials studying Acne Vulgaris
94 Patients Enrolled for Acne Vulgaris