12 and older, any sex, with Acne Vulgaris or Post Inflammatory Hyperpigmentation. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Investigator Global Assessment Scale for Severity of Facial AcnePrimary· Week 4, Week 8, Week 16
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
Group
Value
95% CI
Onexton Gel Application
0
Onexton Gel Application
0
Onexton Gel Application
11
Onexton Gel Application
9
week 8
Group
Value
95% CI
Onexton Gel Application
0
Onexton Gel Application
6
Onexton Gel Application
12
Onexton Gel Application
2
week 16
Group
Value
95% CI
Onexton Gel Application
1
Onexton Gel Application
13
Onexton Gel Application
6
Onexton Gel Application
0
Investigator Global Assessment Scale for Severity of Post Inflammatory HyperpigmentationPrimary· Week 4, Week 8, Week 16
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
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.
The Investigator will count the number of facial non-inflammatory acne lesions at each study visit. these include open and closed comedones.
week 4
Group
Value
95% CI
Onexton Gel Application
-21
± 22
week 8
Group
Value
95% CI
Onexton Gel Application
-41
± 33
week 16
Group
Value
95% CI
Onexton Gel Application
-62
± 32
Percent Change in Total Lesion CountSecondary· week 4, Week 8, Week 16
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.
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
Group
Value
95% CI
Single Arm Onexton Gel Application
0
Single Arm Onexton Gel Application
2
Single Arm Onexton Gel Application
3
Single Arm Onexton Gel Application
6
week 4
Group
Value
95% CI
Single Arm Onexton Gel Application
0
Single Arm Onexton Gel Application
2
Single Arm Onexton Gel Application
3
Single Arm Onexton Gel Application
7
week 8
Group
Value
95% CI
Single Arm Onexton Gel Application
0
Single Arm Onexton Gel Application
2
Single Arm Onexton Gel Application
4
Single Arm Onexton Gel Application
8
week 16
Group
Value
95% CI
Single Arm Onexton Gel Application
0
Single Arm Onexton Gel Application
5
Single Arm Onexton Gel Application
5
Single Arm Onexton Gel Application
5
Adverse events — posted to ClinicalTrials.gov
Time frame: screening to week 16.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Derm Research, PLLC
Last refreshed: 2 April 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03402893.