Laser Therapy for Perioral Dermatitis

Study Overview
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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.

Official Title
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Laser Therapy for Perioral Dermatitis

Conditions
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Perioral Dermatitis

Intervention / Treatment
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* Device: Pulse laser dye therapy (Device name: Candela Family of Pulsed Dye Laser Systems. 501k Number: K050673.)
* Drug: Clindamycin


Participation Criteria
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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. Exclusion Criteria: skin type V or VI (due to risk of hyperpigmentation) pregnant breastfeeding unable to understand English mentally impaired incarcerated

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulse laser therapy<br>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.)<br>* The face will be split and randomized, one half will receive pulsed laser dye therapy.<br>Drug: Clindamycin<br>* The entire face (both halves) will receive clindamycin.<br>|
| Experimental: Clindamycin<br>Clindamycin only applied to side of face that does not receive pulse laser therapy. | Drug: Clindamycin<br>* The entire face (both halves) will receive clindamycin.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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perioral dermatitis, laser therapy