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

Phase 4

Completed

• Conditions: Perioral Dermatitis
• Interventions: Drug: Seysara Oral Product

• Registration Number: NCT06461299
• Lead Sponsor: The Dermatology Institute of Boston

Brief 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.

Study Timeline

• Study Start: 2023-07-17
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31
• Status Verified: 2024-06
• Study First Submitted: 2024-06-11
• Study First Submitted QC: 2024-06-13
• Study First Posted: 2024-06-17
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Have a clinical diagnosis of POD by both the principal investigator and a blinded observer
• Have a PODSI score of 3.0 or greater at baseline by clinical investigator
• Must not be dysphagic.
• Patient is male or female, 18-55 years of age inclusive at Screening.

Exclusion Criteria

• Allergy to tetracyclines.
• Immunocompromised.
• Pregnancy or planning a pregnancy during the study period.
• Lactating subjects.
• Ongoing use of any of the following treatments to the face throughout study; oral or topical steroids, oral or topical calcineurin inhibitors, topical retinoids, topical antibiotics, - oral or topical metronidazole, or topical azelaic acid.
• Facial hair or skin dermatoses that interfere with evaluation of the perioral dermatitis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A Single-ARM Pilot Study to Evaluate Sarecycline for Treating Periorificial Dermatitis	Seysara Oral Product	A Single-Center Pilot Study to Evaluate the Efficacy, Safety, and Tolerability of Sarecycline for Treating Periorificial Dermatitis

Primary Outcome Measures

Name	Time	Method
PODSI score	4 weeks	The PODSI represents the sum of individual scores for erythema, papules and scaling. Each of these key features is graded on a scale from 0 to 3 including intermediate values (0.5, 1.5 and 2.5). The PODSI is defined as the sum score of the 3 features, and may range from 0 to 9. All patients with a PODSI from 0.5 to 2.5 were regarded as mild, whereas severe cases scored with a PODSI from 6.0 to 9.0. All remaining patients with a PODSI from 3.0 to 5.5 were classified as moderate.

Trial Locations

Locations (1)

The Dermatology Institute of Boston; 🇺🇸 Boston, Massachusetts, United States