Phase 3
N=372
A Study of S5G4T-1 in the Treatment of Papularpustular Rosacea
Papulopustular Rosacea
Bottom Line
View on ClinicalTrials.gov: NCT03564119 ↗Enrolled (actual)
372
Serious AEs
0.3%
Results posted
Dec 2021
Primary outcome: Primary: Percentage of Participants Achieving an IGA Score of Clear or Almost Clear From Baseline at Week 12 — 50.1; 25.9 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- S5G4T-1 (Drug); S5G4T-2 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sol-Gel Technologies, Ltd.
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving an IGA Score of Clear or Almost Clear From Baseline at Week 12 |
50.1; 25.9 | — |
| PRIMARY Change From Baseline in Inflammatory Lesion Counts at Week 12 |
-20.3; -13.3 | — |
| SECONDARY Percent Change From Baseline in Inflammatory Lesion Counts at Week 12 |
-69.4; -46.0 | — |
Summary
To assess the efficacy and safety of S5G4T-1 compared to S5G4T-1 vehicle when applied once daily for 12 weeks in participants with papulopustular rosacea.
Eligibility Criteria
Inclusion Criteria
- Participants must sign an Institutional Review Board (IRB) approved written informed consent for this study.
- Male and female 18 years of age and older.
- Participants must have clinical diagnosis of moderate to severe rosacea.
- Have a minimum total of 15 and a maximum of 70 total inflammatory lesions (papules and/or pustules) including those present on the nose.
- Have 2 nodules or less.
Exclusion Criteria
- Females, who are pregnant, breastfeeding, or planning a pregnancy within the period of their study participation or were found to have positive pregnancy test at Baseline or screening visits.
- Presence of more than 2 facial nodules or any nodule greater than 1 centimeter (cm).
- Current or past ocular rosacea (for example, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.
Data sourced from ClinicalTrials.gov (NCT03564119). 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.