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Laser Therapy for Perioral Dermatitis

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ClinicalTrials.gov Identifier: NCT03779295
Recruitment Status : Recruiting
First Posted : December 18, 2018
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
Erica Ghareeb, West Virginia University

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.

Condition or disease Intervention/treatment Phase
Perioral Dermatitis Device: Pulse laser dye therapy (Device name: Candela Family of Pulsed Dye Laser Systems. 501k Number: K050673.) Drug: Clindamycin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Participant)
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.
Primary Purpose: Treatment
Official Title: Laser Therapy for Perioral Dermatitis
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : April 1, 2019


Arm Intervention/treatment
Experimental: Pulse laser therapy applied to right side of face Device: 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.

Drug: Clindamycin
The entire face (both halves) will receive clindamycin.

Experimental: Pulse laser therapy applied to left side of face Device: 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.

Drug: Clindamycin
The entire face (both halves) will receive clindamycin.




Primary Outcome Measures :
  1. Change in number of lesions on side of the subject's face receiving laser therapy [ Time Frame: initial study visit, after 4 weeks, and after 8 weeks ]
    counting number of lesions on each side of the face

  2. Change in number of lesions on side of the subject's face receiving clindamycin alone (NO laser therapy) [ Time Frame: initial study visit, after 4 weeks, and after 8 weeks ]
    counting number of lesions on each side of the face


Secondary Outcome Measures :
  1. Patient opinion of side that improved more [ Time Frame: 4 weeks, 8 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."



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03779295


Contacts
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Contact: Rachael Hagen, BS 3042930615 rmhagen@hsc.wvu.edu

Locations
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United States, West Virginia
West Virginia University University Town Centre Dermatology Clinic Recruiting
Morgantown, West Virginia, United States, 26501
Contact: Building Administrator    304-285-7464    saaids@wvumedicine.org   
Sponsors and Collaborators
West Virginia University

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Responsible Party: Erica Ghareeb, Assistant Professor, West Virginia University
ClinicalTrials.gov Identifier: NCT03779295     History of Changes
Other Study ID Numbers: 1803028429
First Posted: December 18, 2018    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Erica Ghareeb, West Virginia University:
perioral dermatitis
laser therapy
Additional relevant MeSH terms:
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Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Dermatitis
Dermatitis, Perioral
Skin Diseases
Facial Dermatoses
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action