A Study of S5G4T-1 in the Treatment of Papulopustular Rosacea

Sol-Gel Technologies

Status and phase: Completed; Phase 3

Conditions: Papulopustular Rosacea

Treatments: Drug: S5G4T-1; Drug: S5G4T-2

Study type: Interventional

Funder types: Industry

Identifiers

NCT03448939

SGT-54-01

Details and patient eligibility

About

To assess the efficacy and safety of S5G4T-1 compared to its vehicle when applied once daily for 12 weeks in participants with papulopustular rosacea.

Full description

In this Phase 3, double-blind, vehicle-controlled, parallel-group pivotal study, participants will be admitted only after a written informed consent has been obtained and after all inclusion/exclusion criteria have been met. Male and female participants at least 18 years of age with moderate or severe papulopustular rosacea will be eligible for enrollment for daily treatment with S5G4T-1 or its vehicle for 12 weeks.

Enrollment: 361 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants must sign an Institutional Review Board (IRB) approved written informed consent for this study.
2. Male and female 18 years of age and older.
3. Participants must have clinical diagnosis of moderate to severe rosacea.
4. Have a minimum total of 15 and a maximum of 70 total inflammatory lesions (papules and/or pustules) including those present on the nose.
5. Have 2 nodules or less.

Exclusion criteria

1. 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.
2. Presence of more than 2 facial nodules or any nodule greater than 1 centimeter (cm).
3. Current or past ocular rosacea (for example, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

361 participants in 2 patient groups, including a placebo group

S5G4T-1

Experimental group

Description:

Participants will topically apply S5G4T-1 cream, once daily to face for 12 weeks.

Treatment:

Drug: S5G4T-1

S5G4T-2 Vehicle Cream

Placebo Comparator group

Description:

Participants will topically apply S5G4T-2 vehicle cream, once daily to face for 12 weeks.

Treatment:

Drug: S5G4T-2