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

Perioral Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06461299
• Other study ID #: DIB-0601
• Status: Completed
• Phase: Phase 4
• Start date: July 17, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: June 2024
• Source: The Dermatology Institute of Boston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Perioral Dermatitis

Intervention

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.

Locations

Country	Name	City	State
United States	The Dermatology Institute of Boston	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
The Dermatology Institute of Boston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PODSI score	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.	4 weeks