Phase 3
Completed N=436
A Long Term Study of GK530G in Subjects With Acne Vulgaris
Source: ClinicalTrials.gov NCT01910064 ↗Enrolled (actual)
436
Serious AEs
1.4%
Results posted
Jan 2017
Primary outcomePrimary: Local Tolerability (Erythema) — 149; 64; 5 participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This open label study is to determine the safety profile of GK530G in a long-term treatment (up to 12 months) in subjects with acne vulgaris and to evaluate the efficacy of GK530G in a long-term treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Local Tolerability (Erythema) |
149; 64; 5 | — |
| PRIMARY Local Tolerability (Scaling) |
191; 60; 2 | — |
| PRIMARY Local Tolerability (Dryness) |
254; 52; 1 | — |
| PRIMARY Local Tolerability (Pruritus) |
149; 35; 4 | — |
| PRIMARY Local Tolerability (Stinging/Burning) |
251; 79; 9 | — |
| SECONDARY Percent Changes From Baseline in Total Lesion Counts |
25.6; 42.1; 52.9; 67.1; 74.7; 82.0 | — |
Eligibility Criteria
Inclusion Criteria
- Men and women at the age of 12 or older at the Screening visit.
- Those with clinical diagnosis of acne vulgaris with more than 20 non-inflammatory lesions (open and closed comedones) and 12 to 100 (inclusive) inflammatory lesions (papules, pustules and nodules) on the face (forehead, both cheeks, nose and chin).
Exclusion Criteria
- Those with more than two nodular acne lesions or any cyst.
- Those with the diagnosis of any acne conglobata, any acne fulminans, any chloracne, or any drug induced acne.
- Those who have clinically significant abnormal findings or conditions on skin other than acne such as atopic dermatitis, perioral dermatitis, or rosacea that potentially interfere with study assessments according to Investigator's judgment
Data sourced from ClinicalTrials.gov (NCT01910064). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.