Seborrheic DermatitisEarly Phase 1NCT03114111
Pilot Study for the Use of Photodynamic Therapy in the Treatment of Seborrheic Dermatitis
A Early Phase 1 study testing aminolevulinic acid (ALA) in people with Seborrheic Dermatitis, run by University of California, Davis at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seborrheic Dermatitis
- What is being tested?
- aminolevulinic acid (ALA)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 4 Dec 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy subjects 18 years or older with seborrheic dermatitis of the face will be included.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis
Sacramento, California
About this study
The purpose of this study is:
- To determine the efficacy of photodynamic therapy (PDT) in the treatment of seborrheic dermatitis.
- To determine how PDT alters the skin microbiome in subjects with seborrheic dermatitis before and after treatment.
- 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.
Read the 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.
- Conditions
- Seborrheic Dermatitis
- Being tested
- aminolevulinic acid (ALA), Placebo
- Medical subject headings
- Dermatitis, Seborrheic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aminolevulinic acid (ALA)Drug
Also called LEVULAN® KERASTICK®
PlaceboDrug
Also called Demo Levulan Kerastick
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of seborrheic dermatitis before and after ALA treatment as determined by Seborrhea Area and Severity Index Face (SASI-F)
Measured: up to 3 months
Secondary outcomes (2)
microbiome analysis before and after ALA treatment
Measured: up to 3 months
facial sebum production rates before and after ALA treatment
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study startJan 2017
- Primary completion4 Dec 2019
- Study completion4 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seborrheic DermatitisStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114111
- Sponsor's protocol ID
- 408732
- Status last verified
- Aug 2021
- First submitted
- 14 Feb 2017
- Last updated
- 11 Aug 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for the Use of Photodynamic Therapy in the Treatment of Seborrheic Dermatitis
- ClinicalTrials.gov ID
- NCT03114111
- Acronym / sponsor ID
- 408732
- Conditions
- Seborrheic Dermatitis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- 4 Dec 2019 (actual)
- Study completion
- 4 Dec 2019 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is:
- To determine the efficacy of photodynamic therapy (PDT) in the treatment of seborrheic dermatitis.
- To determine how PDT alters the skin microbiome in subjects with seborrheic dermatitis before and after treatment.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Application of ALA | Active comparator | Drug: aminolevulinic acid (ALA)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. |
| No Application of ALA | Placebo comparator | Drug: PlaceboFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy subjects 18 years or older with seborrheic dermatitis of the face will be included.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aminolevulinic acid (ALA)Also: LEVULAN® KERASTICK® | Drug | Application of ALA |
| PlaceboAlso: Demo Levulan Kerastick | Drug | No Application of ALA |
Primary outcome
severity of seborrheic dermatitis before and after ALA treatment as determined by Seborrhea Area and Severity Index Face (SASI-F)
Time frame: up to 3 months
2 secondary outcomes
microbiome analysis before and after ALA treatment
Time frame: up to 3 months
facial sebum production rates before and after ALA treatment
Time frame: up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing aminolevulinic acid (ALA) in people with Seborrheic Dermatitis, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severity of seborrheic dermatitis before and after ALA treatment as determined by Seborrhea Area and Severity Index Face (SASI-F) (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2021.