N/A
N=7
Photocil (Topical) for the Treatment of Atopic Dermatitis
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT01992172 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Number of Pruritus Events in Last 30 Days — 7.4; 1.9 Events
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Photocil for Atopic Dermatitis (Drug); Placebo - Sunscreen (SPF 2) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Applied Biology, Inc.
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Pruritus Events in Last 30 Days |
7.4; 1.9 | — |
Summary
Photocil is a topical drug (cream) that selectively delivers Narrow Band - Ultraviolet B (NB-UVB) therapy when exposed to sunlight. Photocil is intended to help protect users from non-therapeutic Ultraviolet B (UVB) radiation while selectively passing wavelengths of light in the NB-UVB range with peak transmission of 308nm. The aim of the study is to assess the safety and efficacy of Photocil in the treatment of atopic dermatitis.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with atopic dermatitis confirmed by a dermatologist
- Atopic dermatitis lesions affecting at a minimum 5% of the facial, legs, or arms surface area
- Age: 18 to 65
- Participants able to give informed consent
Exclusion Criteria
- Subject did not respond to prior phototherapy treatment
- Subject completed phototherapy for same lesion(s) in last 6 months
- Subject has previous history of skin cancer
- Subject has previous history of photosensitivity
- Subject has a history of herpes (HSV I or II) outbreaks
- Subject has previous history of autoimmune disease may be excluded at investigator's discretion
- Subject is currently taking of immunosuppressive or photosensitizing drugs
- Subject plans to use antibiotics, anti-fungal, calcineurin inhibitors or other drugs that may cause photosensitivity during the study period. These patients may be excluded at investigator's discretion
- Subject is pregnant or lactating women
Data sourced from ClinicalTrials.gov (NCT01992172). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.