NCT06461299

Study to Evaluate the Efficacy, Safety, and Tolerability of Sarecycline for Treating Periorificial Dermatitis

A Single-Center Pilot Study to Evaluate the Efficacy, Safety, and Tolerability of Sarecycline for Treating Periorificial Dermatitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: The Dermatology Institute of Boston · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A Single-Center Pilot Study to Evaluate the Efficacy, Safety, and Tolerability of Sarecycline for Treating Periorificial Dermatitis

Detailed description

This pilot study's intended purpose is to evaluate the efficacy, safety, and tolerability of sarecycline for periorificial dermatitis. Sarecycline, a third-generation tetracycline, is currently only indicated to treat acne vulgaris. However, the investigator has used sarecycline to treat periorificial dermatitis and would like to capture and report on this efficacy in a pilot study. The investigator hypothesize's that not only will the subjects respond well to sarecycline treatment, but that it will be well-tolerated.

Conditions

• Perioral Dermatitis

Interventions

Type	Name	Description
DRUG	Seysara Oral Product	Subjects with a clinical diagnosis of POD will be given sarecycline for four weeks. Dosing of sarecycline will be weight based, either 60mg, 100mg, or 150mg PO qday. Each subject will have at least three visits, including a screening/baseline visit, a two-week follow-up, and a four-week follow-up. The initial diagnosis will be made by a board-certified dermatologist or a dermatology-certified nurse practitioner. The Perioral Dermatitis Severity Index, PODSI, (Appendix I) will be used to grade the severity of periorificial dermatitis throughout the three visits. This published scoring method ranges from 0 to 9. To be included in the study, patients must need to have a PODSI score of "moderate" (PODSI = 3.0-5.5) or "severe" (PODSI = 6.0-9.0) at baseline. The primary endpoint is the percentage of patients that receive a PODSI score ranging from 0 ("none") to 2.5 ("mild") at week four. The secondary endpoint is the patient reported an adverse event at week four.

Timeline

• Start date: 2023-07-17
• Primary completion: 2024-03-31
• Completion: 2024-03-31
• First posted: 2024-06-17
• Last updated: 2024-06-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study