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Laser Therapy for Perioral Dermatitis

Primary Purpose

Perioral Dermatitis

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pulse laser dye therapy (Device name: Candela Family of Pulsed Dye Laser Systems. 501k Number: K050673.)
Clindamycin
Sponsored by
West Virginia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perioral Dermatitis focused on measuring perioral dermatitis, laser therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • West Virginia University University Town Centre Dermatology Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pulse laser therapy

Clindamycin

Arm Description

Pulse laser therapy will be randomly applied to right side or left side of face in addition to Clindamycin

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

Outcomes

Primary Outcome Measures

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
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
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
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
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
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

Secondary Outcome Measures

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."
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."

Full Information

First Posted
December 12, 2018
Last Updated
February 14, 2022
Sponsor
West Virginia University
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1. Study Identification

Unique Protocol Identification Number
NCT03779295
Brief Title
Laser Therapy for Perioral Dermatitis
Official Title
Laser Therapy for Perioral Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Withdrawn
Why Stopped
No subjects enrolled.
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
June 5, 2019 (Actual)
Study Completion Date
June 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Virginia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perioral Dermatitis
Keywords
perioral dermatitis, laser therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulse laser therapy
Arm Type
Experimental
Arm Description
Pulse laser therapy will be randomly applied to right side or left side of face in addition to Clindamycin
Arm Title
Clindamycin
Arm Type
Experimental
Arm Description
Clindamycin only applied to side of face that does not receive pulse laser therapy.
Intervention Type
Device
Intervention Name(s)
Pulse laser dye therapy (Device name: Candela Family of Pulsed Dye Laser Systems. 501k Number: K050673.)
Intervention Description
The face will be split and randomized, one half will receive pulsed laser dye therapy.
Intervention Type
Drug
Intervention Name(s)
Clindamycin
Intervention Description
The entire face (both halves) will receive clindamycin.
Primary Outcome Measure Information:
Title
Change in number of lesions on side of the subject's face receiving laser therapy
Description
counting number of lesions on each side of the face
Time Frame
initial study visit
Title
Change in number of lesions on side of the subject's face receiving laser therapy
Description
counting number of lesions on each side of the face
Time Frame
4 weeks
Title
Change in number of lesions on side of the subject's face receiving laser therapy
Description
counting number of lesions on each side of the face
Time Frame
8 weeks
Title
Change in number of lesions on side of the subject's face receiving clindamycin alone (NO laser therapy)
Description
counting number of lesions on each side of the face
Time Frame
initial study visit
Title
Change in number of lesions on side of the subject's face receiving clindamycin alone (NO laser therapy)
Description
counting number of lesions on each side of the face
Time Frame
4 weeks
Title
Change in number of lesions on side of the subject's face receiving clindamycin alone (NO laser therapy)
Description
counting number of lesions on each side of the face
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Patient opinion of side that improved more
Description
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."
Time Frame
4 weeks
Title
Patient opinion of side that improved more
Description
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."
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
West Virginia University University Town Centre Dermatology Clinic
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26501
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Laser Therapy for Perioral Dermatitis

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