Photocil (Topical) for the Treatment of Atopic Dermatitis
Pilot Study of Novel Topical Drug (Photocil) for the Treatment of Atopic Dermatitis
1 other identifier
interventional
7
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 19, 2013
CompletedFirst Posted
Study publicly available on registry
November 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
March 25, 2016
CompletedMarch 25, 2016
February 1, 2016
1.3 years
November 19, 2013
December 11, 2015
February 25, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Pruritus Events in Last 30 Days
30 days from baseline
Study Arms (2)
Photocil for Atopic Dermatitis
ACTIVE COMPARATORActive Drug - Photocil for Atopic Dermatitis
Placebo - Sunscreen (SPF 2)
PLACEBO COMPARATORPlacebo - Sunscreen (SPF 2)
Interventions
Photocil for Atopic Dermatitis
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Physicians Institute
Tucson, Arizona, 85719, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sharon Keene, MD
- Organization
- Physicians Institute
Study Officials
- STUDY DIRECTOR
John McCoy, PhD
Applied Biology, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2013
First Posted
November 25, 2013
Study Start
August 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
March 25, 2016
Results First Posted
March 25, 2016
Record last verified: 2016-02