N/A
N=15
Photocil (Topical) for the Treatment of Vitiligo
Vitiligo
Bottom Line
View on ClinicalTrials.gov: NCT01992185 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Percent Repigmentation — 48.5; 2.5 Percent Repigmentation
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Photocil for Vitiligo (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 Percent Repigmentation |
48.5; 2.5 | — |
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 vitiligo.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with vitiligo confirmed by a dermatologist
- Vitiligo 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 (NCT01992185). 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.