Laser Therapy for Perioral Dermatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2019-06-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Perioral Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This will be a split face prospective trial. The face will be treated in halves. The halves will be randomized to receive topical clindamycin or PDL therapy and clindamycin. Both halves of the face will be treated with topical clindamycin. Per randomization, half of the face will be treated with pulse dye laser therapy at 595 nm, using 6.5 J/cm2, 10 mm spot size and a 6 millisecond pulse width.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

The investigators will not remind the participant or other investigators which side of the face received laser therapy, however the investigators cannot completely "blind" either the participant or other investigators as they will be awake or performing the therapy, respectively.

Study Groups

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Pulse laser therapy

Pulse laser therapy will be randomly applied to right side or left side of face in addition to Clindamycin

Group Type EXPERIMENTAL

Pulse laser dye therapy (Device name: Candela Family of Pulsed Dye Laser Systems. 501k Number: K050673.)

Intervention Type DEVICE

The face will be split and randomized, one half will receive pulsed laser dye therapy.

Clindamycin

Intervention Type DRUG

The entire face (both halves) will receive clindamycin.

Clindamycin

Clindamycin only applied to side of face that does not receive pulse laser therapy.

Group Type EXPERIMENTAL

Clindamycin

Intervention Type DRUG

The entire face (both halves) will receive clindamycin.

Interventions

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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.

Intervention Type DEVICE

Clindamycin

The entire face (both halves) will receive clindamycin.

Intervention Type DRUG

Eligibility Criteria

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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.