Laser Therapy for Perioral Dermatitis

Perioral Dermatitis Clinical Trial

Official title:

Laser Therapy for Perioral Dermatitis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03779295
• Other study ID #: 1803028429
• Status: Withdrawn
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: June 5, 2019

Study information

• Verified date: February 2022
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 5, 2019
• Est. primary completion date: June 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Perioral Dermatitis

Intervention

Device:
• Pulse laser dye therapy (Device name: Candela Family of Pulsed Dye Laser Systems. 501k Number: K050673.)
The face will be split and randomized, one half will receive pulsed laser dye therapy.

Drug:
• Clindamycin
The entire face (both halves) will receive clindamycin.

Locations

Country	Name	City	State
United States	West Virginia University University Town Centre Dermatology Clinic	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of lesions on side of the subject's face receiving laser therapy	counting number of lesions on each side of the face	initial study visit
Primary	Change in number of lesions on side of the subject's face receiving laser therapy	counting number of lesions on each side of the face	4 weeks
Primary	Change in number of lesions on side of the subject's face receiving laser therapy	counting number of lesions on each side of the face	8 weeks
Primary	Change in number of lesions on side of the subject's face receiving clindamycin alone (NO laser therapy)	counting number of lesions on each side of the face	initial study visit
Primary	Change in number of lesions on side of the subject's face receiving clindamycin alone (NO laser therapy)	counting number of lesions on each side of the face	4 weeks
Primary	Change in number of lesions on side of the subject's face receiving clindamycin alone (NO laser therapy)	counting number of lesions on each side of the face	8 weeks
Secondary	Patient opinion of side that improved more	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."	4 weeks
Secondary	Patient opinion of side that improved more	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."	8 weeks