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

NCT03114111 | Completed Early Phase 1

• 1 other identifier: 408732
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is:

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

Conditions

Seborrheic Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• microbiome analysis before and after ALA treatment

  up to 3 months

• facial sebum production rates before and after ALA treatment

  up to 3 months

Study Arms (2)

Application of ALA

ACTIVE COMPARATOR

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)

No Application of ALA

PLACEBO COMPARATOR

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

Interventions

aminolevulinic acid (ALA) DRUG

Also known as: LEVULAN® KERASTICK®

Application of ALA

Placebo DRUG

Also known as: Demo Levulan Kerastick

No Application of ALA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis

Sacramento, California, United States

Location

MeSH Terms

Conditions

Dermatitis, Seborrheic

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Skin Diseases, Eczematous; Skin Diseases, Papulosquamous

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: April 14, 2017
• Study Start: January 1, 2017
• Primary Completion: December 4, 2019
• Study Completion: December 4, 2019
• Last Updated: August 11, 2021

Record last verified: 2021-08

Locations

US (1)