Perioral Dermatitis
Conditions
Keywords
perioral dermatitis, laser therapy
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.
Interventions
DEVICEPulse 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.
DRUGClindamycin
The entire face (both halves) will receive clindamycin.
Sponsors
West Virginia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in number of lesions on side of the subject's face receiving laser therapy | initial study visit | counting number of lesions on each side of the face |
| Change in number of lesions on side of the subject's face receiving clindamycin alone (NO laser therapy) | initial study visit | counting number of lesions on each side of the face |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient opinion of side that improved more | 4 weeks | 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. |
Countries
United States
Outcome results
None listed