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

NCT ID: NCT06461299

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-17
• Study Completion Date: 2024-03-31

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.

Conditions

Perioral Dermatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A Single-ARM Pilot Study to Evaluate Sarecycline for Treating Periorificial Dermatitis

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

Group Type: EXPERIMENTAL

Seysara Oral Product

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Dermatology Institute of Boston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Dermatology Institute of Boston

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

DIB-0601

Identifier Type: -

Identifier Source: org_study_id