Seborrheic Dermatitis Clinical Trial
Official title:
Pilot Study for the Use of Photodynamic Therapy in the Treatment of Seborrheic Dermatitis
Verified date | August 2021 |
Source | University of California, Davis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of California, Davis | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis |
United States,
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 |
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