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

Seborrheic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03114111
• Other study ID #: 408732
• Status: Completed
• Phase: Early Phase 1
• Start date: January 2017
• Est. completion date: December 4, 2019

Study information

• Verified date: August 2021
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 4, 2019
• Est. primary completion date: December 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Seborrheic
• Seborrheic Dermatitis

Intervention

Drug:
• aminolevulinic acid (ALA)

• Placebo

Locations

Country	Name	City	State
United States	University of California, Davis	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	microbiome analysis before and after ALA treatment		up to 3 months
Secondary	facial sebum production rates before and after ALA treatment		up to 3 months