Laser Therapy for Perioral Dermatitis

NCT03779295 | Withdrawn DMC FDA Device

• 1 other identifier: 1803028429
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Perioral Dermatitis

Keywords

perioral dermatitis; laser therapy

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Patient opinion of side that improved more

  4 weeks

• Patient opinion of side that improved more

  8 weeks

Study Arms (2)

Pulse laser therapy

EXPERIMENTAL

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.); Drug: Clindamycin

Clindamycin

EXPERIMENTAL

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

Drug: Clindamycin

Interventions

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

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

Pulse laser therapy

Clindamycin DRUG

The entire face (both halves) will receive clindamycin.

Clindamycin; Pulse laser therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• skin type V or VI (due to risk of hyperpigmentation)
• pregnant
• breastfeeding
• unable to understand English
• mentally impaired
• incarcerated

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University University Town Centre Dermatology Clinic

Morgantown, West Virginia, 26501, United States

Location

MeSH Terms

Conditions

Dermatitis, Perioral

Interventions

Clindamycin

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Facial Dermatoses

Intervention Hierarchy (Ancestors)

Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: December 19, 2018
• Study Start: November 1, 2018
• Primary Completion: June 5, 2019
• Study Completion: June 5, 2019
• Last Updated: March 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)