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Completed

NCT Number: NCT06461299

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

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

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Key information

Conditions

Perioral Dermatitis Dermatitis Dermatitis, Perioral Facial Dermatoses Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Dermatology Institute of Boston

Boston, Massachusetts, 02116, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. PODSI score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Dermatology Institute of Boston

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 17, 2024
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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