Laser Therapy for Perioral Dermatitis

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.

Study Overview

• Status: Withdrawn
• Conditions: Perioral Dermatitis
• Intervention / Treatment: Device: Pulse laser dye therapy (Device name: Candela Family of Pulsed Dye Laser Systems. 501k Number: K050673.); Drug: Clindamycin

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • West Virginia
    • Morgantown, West Virginia, United States, 26501
      • West Virginia University University Town Centre Dermatology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pulse laser therapy; Pulse laser therapy will be randomly applied to right side or left side of face in addition to Clindamycin	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.
Experimental: Clindamycin; Clindamycin only applied to side of face that does not receive pulse laser therapy.	Drug: Clindamycin; The entire face (both halves) will receive clindamycin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: West Virginia University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): June 5, 2019
• Study Completion (Actual): June 5, 2019

Study Registration Dates

• First Submitted: December 12, 2018
• First Submitted That Met QC Criteria: December 14, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): March 3, 2022
• Last Update Submitted That Met QC Criteria: February 14, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: laser therapy; perioral dermatitis
• Additional Relevant MeSH Terms: Skin Diseases; Facial Dermatoses; Dermatitis; Dermatitis, Perioral; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Clindamycin; Clindamycin palmitate; Clindamycin phosphate
• Other Study ID Numbers: 1803028429

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes