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

NCT06461299 | Completed Phase 4 FDA Drug

• 1 other identifier: DIB-0601
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Perioral Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

EXPERIMENTAL

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

Drug: Seysara Oral Product

Interventions

Seysara Oral Product 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.

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Dermatology Institute of Boston: lead

Study Sites (1)

The Dermatology Institute of Boston

Boston, Massachusetts, 02116, United States

Location

MeSH Terms

Conditions

Dermatitis, Perioral

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Facial Dermatoses

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-center, prospective, pilot study to evaluate the efficacy, safety, and tolerability of sarecycline (Seysara) for periorificial dermatitis. This will be a four-week open-label study using sarecycline to treat POD.

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 17, 2024
• Study Start: July 17, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

US (1)