Laser Therapy for Perioral Dermatitis

Not Applicable

Withdrawn

• Conditions: Perioral Dermatitis
• Interventions: Drug: Clindamycin

• Registration Number: NCT03779295
• Lead Sponsor: West Virginia University

Brief Summary

Perioral dermatitis is an inflammation of the skin around the mouth. The cause of perioral dermatitis is unknown. Current treatment methods include oral antibiotics and topical calcenurin inhibitors, both of which produce side effects and have been relatively ineffective in the treatment of perioral dermatitis. The investigators hope to assess the efficacy of laser therapy in treatment of perioral dermatitis by using laser therapy on one half of the patients face and having patients apply topical medication (clindamycin) to their face for 8 weeks. The side of their face that receives laser therapy will be randomized. The investigators will assess the efficacy of laser therapy by counting the number of lesions that patients have before and after laser therapy, comparing photos of patient's perioral dermatitis before and after treatment, and having patient's rate their satisfaction of the treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-01
• Study First Submitted: 2018-12-12
• Study First Submitted QC: 2018-12-14
• Study First Posted: 2018-12-19
• Primary Completion: 2019-06-05
• Study Completion: 2019-06-05
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-14
• Last Update Posted: 2022-03-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• age 18 years or older
• perioral dermatitis for greater than 1 month
• willing to return for follow-up visits 2 weeks, 4 weeks and 8 weeks following treatment.

Exclusion Criteria

• skin type V or VI (due to risk of hyperpigmentation)
• pregnant
• breastfeeding
• unable to understand English
• mentally impaired
• incarcerated

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulse laser therapy	Clindamycin	Pulse laser therapy will be randomly applied to right side or left side of face in addition to Clindamycin
Clindamycin	Clindamycin	Clindamycin only applied to side of face that does not receive pulse laser therapy.

Primary Outcome Measures

Name	Time	Method
Change in number of lesions on side of the subject's face receiving laser therapy	8 weeks	counting number of lesions on each side of the face
Change in number of lesions on side of the subject's face receiving clindamycin alone (NO laser therapy)	8 weeks	counting number of lesions on each side of the face

Secondary Outcome Measures

Name	Time	Method
Patient opinion of side that improved more	8 weeks	Patients will grade satisfaction of treatment by answering "Which side of their face improved more from treatment?" with the option of responding "the right side/the left side/they are the same."

Trial Locations

Locations (1)

West Virginia University University Town Centre Dermatology Clinic; 🇺🇸 Morgantown, West Virginia, United States