Phase 3
Completed N=372
A Study of S5G4T-1 in the Treatment of Papularpustular Rosacea
Papulopustular Rosacea
Source: ClinicalTrials.gov NCT03564119 ↗
Enrolled (actual)
372
Serious AEs
0.3%
Results posted
Dec 2021
Primary outcomePrimary: Percentage of Participants Achieving an IGA Score of Clear or Almost Clear From Baseline at Week 12 — 50.1; 25.9 Percentage of Participants
◆ Published Evidence
Emerging
11citations · ~4 / year
Efficacy and Safety of Microencapsulated Benzoyl Peroxide Cream, 5%, in Rosacea: Results From Two Phase III, Randomized, Vehicle-Controlled Trials.
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.
Linked Publications
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Efficacy and Safety of Microencapsulated Benzoyl Peroxide Cream, 5%, in Rosacea: Results From Two Phase III, Randomized, Vehicle-Controlled Trials.
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 | — |
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) and the linked publication. 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.