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

The purpose of this study is:

1. To determine the efficacy of photodynamic therapy (PDT) in the treatment of seborrheic dermatitis.
2. To determine how PDT alters the skin microbiome in subjects with seborrheic dermatitis before and after treatment.
3. 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.

Study Overview

• Status: Completed
• Conditions: Seborrheic Dermatitis
• Intervention / Treatment: Drug: Placebo; Drug: aminolevulinic acid (ALA)

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States
      • University of California, Davis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Application of ALA; 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.	Drug: aminolevulinic acid (ALA); Other Names: LEVULAN® KERASTICK®
Placebo Comparator: No Application of ALA; 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.	Drug: Placebo; Other Names: Demo Levulan Kerastick

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
severity of seborrheic dermatitis before and after ALA treatment as determined by Seborrhea Area and Severity Index Face (SASI-F)	up to 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
microbiome analysis before and after ALA treatment	up to 3 months
facial sebum production rates before and after ALA treatment	up to 3 months

Collaborators and Investigators

• Sponsor: University of California, Davis

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Actual): December 4, 2019
• Study Completion (Actual): December 4, 2019

Study Registration Dates

• First Submitted: February 14, 2017
• First Submitted That Met QC Criteria: April 10, 2017
• First Posted (Actual): April 14, 2017

Study Record Updates

• Last Update Posted (Actual): August 11, 2021
• Last Update Submitted That Met QC Criteria: August 4, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Skin Diseases, Eczematous; Sebaceous Gland Diseases; Dermatitis; Dermatitis, Seborrheic; Photosensitizing Agents; Dermatologic Agents; Aminolevulinic Acid
• Other Study ID Numbers: 408732