Clinical trial NCT03779295: Laser Therapy for Perioral Dermatitis
Official title: Laser Therapy for Perioral Dermatitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Perioral Dermatitis
Keywords: perioral dermatitis
laser therapy
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in number of lesions on side of the subject's face receiving laser therapy
timeFrame: initial study visit
measure: Change in number of lesions on side of the subject's face receiving laser therapy
timeFrame: 4 weeks
measure: Change in number of lesions on side of the subject's face receiving laser therapy
timeFrame: 8 weeks
measure: Change in number of lesions on side of the subject's face receiving clindamycin alone (NO laser therapy)
timeFrame: initial study visit
measure: Change in number of lesions on side of the subject's face receiving clindamycin alone (NO laser therapy)
timeFrame: 4 weeks
measure: Change in number of lesions on side of the subject's face receiving clindamycin alone (NO laser therapy)
timeFrame: 8 weeks
Secondary outcomes:
measure: Patient opinion of side that improved more
timeFrame: 4 weeks
measure: Patient opinion of side that improved more
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University University Town Centre Dermatology Clinic
state: West Virginia
Study officials:
References: