The Use of Onexton in Moderate Acne Vulgaris for Patients With Skin of Color
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|ClinicalTrials.gov Identifier: NCT03402893|
Recruitment Status : Completed
First Posted : January 18, 2018
Results First Posted : February 19, 2019
Last Update Posted : April 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris Post Inflammatory Hyperpigmentation||Drug: ONEXTON Topical Gel||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of Onexton in Moderate Acne Vulgaris for Patients With Skin of Color|
|Actual Study Start Date :||July 28, 2017|
|Actual Primary Completion Date :||November 15, 2017|
|Actual Study Completion Date :||February 28, 2018|
Experimental: single arm Onexton gel application
Onexton gel will be supplied to all subjects and applied once daily to the face
Drug: ONEXTON Topical Gel
Onexton gel applied once daily to face
- Investigator Global Assessment Scale for Severity of Facial Acne [ Time Frame: 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.
- Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation [ Time Frame: 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
- Percent Change in Inflammatory Lesions [ Time Frame: Week 4, Week 8, Week 16 ]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.
- Percent Change in Non-inflammatory Lesion Count [ Time Frame: Week 4, Week 8, Week 16 ]The Investigator will count the number of facial non-inflammatory acne lesions at each study visit. these include open and closed comedones.
- Percent Change in Total Lesion Count [ Time Frame: 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.
- Post-Inflammatory Hyperpigmentation (PIH) Distribution [ Time Frame: baseline, Week 4, week 8, week 16 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03402893
|United States, Kentucky|
|Louisville, Kentucky, United States, 40217|