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Pilot Study for the Use of Photodynamic Therapy in the Treatment of Seborrheic Dermatitis

Primary Purpose

Seborrheic Dermatitis

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
aminolevulinic acid (ALA)
Placebo
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seborrheic Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Healthy subjects 18 years or older with seborrheic dermatitis of the face will be included.

Exclusion Criteria:

  • Subjects who are taking systemic corticosteroids (at doses of prednisone greater than or equal to 5 mg daily), antibiotics (PO, IM or IV) or using topical anti- fungals, steroids, antibiotics, permethrin, or calcineurin inhibitors within 2 weeks prior to the study will be excluded.
  • The exclusion criteria will also include the presence of other untreated inflammatory conditions (such as lupus, atopic dermatitis, or psoriasis) or untreated malignancies on the face (including skin cancers such as basal cell carcinoma, squamous cell carcinoma and melanoma).
  • Any subjects with known or suspected hypersensitivity to any constituent of the study medication or a history of photosensitivity due to conditions such as lupus erythematosus and porphyria will be excluded.
  • Subjects who have had photodynamic therapy (PDT) to the face for any reason within the past year will be excluded as well.
  • Adults unable to consent, individuals under the age of 18, pregnant or breastfeeding women and prisoners will be excluded from the study.

Sites / Locations

  • University of California, Davis

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Application of ALA

No Application of ALA

Arm Description

The treatment will consist of split-face comparisons of no application of aminolevulinic acid (ALA) vs ALA application to either half of the face. Prior to ALA application, the face will be swabbed for microbiome analysis. After the ALA application, the subjects will incubate with the ALA on their face per the standard PDT protocol used at UC Davis Dermatology clinic for facial PDT treatments. The side of the face being treated will remain the same during all treatments.

For the placebo, Demo Levulan Kerastick, which contains no active ingredient and is enclosed in same cardboard sleeve and cap, will be applied to the other side of the face to mimic the surface of the ALA application stick. After the placebo application, the subjects will incubate with the placebo on their face per the standard PDT protocol used at UC Davis Dermatology clinic for facial PDT treatments. The side of the face being treated will remain the same during all treatments.

Outcomes

Primary Outcome Measures

severity of seborrheic dermatitis before and after ALA treatment as determined by Seborrhea Area and Severity Index Face (SASI-F)

Secondary Outcome Measures

microbiome analysis before and after ALA treatment
facial sebum production rates before and after ALA treatment

Full Information

First Posted
February 14, 2017
Last Updated
August 4, 2021
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT03114111
Brief Title
Pilot Study for the Use of Photodynamic Therapy in the Treatment of Seborrheic Dermatitis
Official Title
Pilot Study for the Use of Photodynamic Therapy in the Treatment of Seborrheic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 2017 (undefined)
Primary Completion Date
December 4, 2019 (Actual)
Study Completion Date
December 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is: To determine the efficacy of photodynamic therapy (PDT) in the treatment of seborrheic dermatitis. To determine how PDT alters the skin microbiome in subjects with seborrheic dermatitis before and after treatment. To determine how PDT alters sebum secretion rates in subjects with seborrheic dermatitis before and after treatment. The researchers hypothesize that PDT will be efficacious in the treatment of seborrheic dermatitis.
Detailed Description
This pilot project investigates the use of PDT may be useful in the treatment of seborrheic dermatitis based on the following: The Malassezia spp is capable of forming biofilms, 2) PDT has been shown to be effective against Malassezia spp PDT can break up bioflims of both bacterial and fungal origin and benzoyl peroxide, a prooxidant treatment similar to PDT, has been shown to be effective in the treatment of seborrheic dermatitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seborrheic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Application of ALA
Arm Type
Active Comparator
Arm Description
The treatment will consist of split-face comparisons of no application of aminolevulinic acid (ALA) vs ALA application to either half of the face. Prior to ALA application, the face will be swabbed for microbiome analysis. After the ALA application, the subjects will incubate with the ALA on their face per the standard PDT protocol used at UC Davis Dermatology clinic for facial PDT treatments. The side of the face being treated will remain the same during all treatments.
Arm Title
No Application of ALA
Arm Type
Placebo Comparator
Arm Description
For the placebo, Demo Levulan Kerastick, which contains no active ingredient and is enclosed in same cardboard sleeve and cap, will be applied to the other side of the face to mimic the surface of the ALA application stick. After the placebo application, the subjects will incubate with the placebo on their face per the standard PDT protocol used at UC Davis Dermatology clinic for facial PDT treatments. The side of the face being treated will remain the same during all treatments.
Intervention Type
Drug
Intervention Name(s)
aminolevulinic acid (ALA)
Other Intervention Name(s)
LEVULAN® KERASTICK®
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Demo Levulan Kerastick
Primary Outcome Measure Information:
Title
severity of seborrheic dermatitis before and after ALA treatment as determined by Seborrhea Area and Severity Index Face (SASI-F)
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
microbiome analysis before and after ALA treatment
Time Frame
up to 3 months
Title
facial sebum production rates before and after ALA treatment
Time Frame
up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Healthy subjects 18 years or older with seborrheic dermatitis of the face will be included. Exclusion Criteria: Subjects who are taking systemic corticosteroids (at doses of prednisone greater than or equal to 5 mg daily), antibiotics (PO, IM or IV) or using topical anti- fungals, steroids, antibiotics, permethrin, or calcineurin inhibitors within 2 weeks prior to the study will be excluded. The exclusion criteria will also include the presence of other untreated inflammatory conditions (such as lupus, atopic dermatitis, or psoriasis) or untreated malignancies on the face (including skin cancers such as basal cell carcinoma, squamous cell carcinoma and melanoma). Any subjects with known or suspected hypersensitivity to any constituent of the study medication or a history of photosensitivity due to conditions such as lupus erythematosus and porphyria will be excluded. Subjects who have had photodynamic therapy (PDT) to the face for any reason within the past year will be excluded as well. Adults unable to consent, individuals under the age of 18, pregnant or breastfeeding women and prisoners will be excluded from the study.
Facility Information:
Facility Name
University of California, Davis
City
Sacramento
State/Province
California
Country
United States

12. IPD Sharing Statement

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Pilot Study for the Use of Photodynamic Therapy in the Treatment of Seborrheic Dermatitis

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