Clinical trial NCT03114111: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Seborrheic Dermatitis
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: severity of seborrheic dermatitis before and after ALA treatment as determined by Seborrhea Area and Severity Index Face (SASI-F)
timeFrame: up to 3 months
Secondary outcomes:
measure: microbiome analysis before and after ALA treatment
timeFrame: up to 3 months
measure: facial sebum production rates before and after ALA treatment
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis
state: California
Study officials:
References: