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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03114111

Enrollment

Registered

2017-04-14

Start date

2017-01-31

Completion date

2019-12-04

Last updated

2021-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seborrheic Dermatitis

Brief 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.

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.

Interventions

DRUGaminolevulinic acid (ALA)

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026