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

The Dermatology Institute of Boston

Status and phase

Completed

Phase 4

Conditions

Perioral Dermatitis

Treatments

Drug: Seysara Oral Product

Study type

Interventional

Funder types

Other

Identifiers

NCT06461299

DIB-0601

Details and patient eligibility

About

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

Full 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.

Enrollment

9 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.