Photocil (Topical) for the Treatment of Psoriasis Vulgaris
Primary Purpose
Psoriasis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Photocil for Psoriasis
Placebo - Sunscreen (SPF 2)
Sponsored by

About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with psoriasis vulgaris confirmed by a dermatologist
- Psoriasis 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
Sites / Locations
- Physicians Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Photocil for Psoriasis
Placebo - Sunscreen (SPF 2)
Arm Description
Active Drug - Photocil for Psoriasis
Placebo - Sunscreen (SPF 2)
Outcomes
Primary Outcome Measures
Percent Lesion Clearance
Secondary Outcome Measures
Full Information
NCT ID
NCT01916629
First Posted
August 1, 2013
Last Updated
February 12, 2016
Sponsor
Applied Biology, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01916629
Brief Title
Photocil (Topical) for the Treatment of Psoriasis Vulgaris
Official Title
Pilot Study of Novel Topical Drug (Photocil) for the Treatment of Psoriasis Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Applied Biology, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 psoriasis
Detailed Description
NB-UVB phototherapy is a common treatment for patients with psoriasis, and has been reported to be safe and effective in numerous clinical trials. Clinical trials have reported achievement of Psoriasis Area Severity Index (PASI)-75 in 50-70% of patients after 4-6 weeks of NB-UVB treatment.
Many drawbacks limit patients compliance, access, and acceptance of traditional NB-UVB phototherapy. The strict treatment regimen (2-3 sessions per week for an average of 12 weeks or more) performed at a specialized phototherapy clinic combined with high cost and low or no reimbursement make compliance and access a major drawback.
In order to address the drawbacks of phototherapy, we developed a novel topical cream - Photocil - that selectively delivers NB-UVB therapy when exposed to sunlight. When used with natural sunlight, Photocil provides a convenient alternative to traditional clinic based phototherapy; thus, has the potential to dramatically increase patient compliance and treatment outcome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Photocil for Psoriasis
Arm Type
Active Comparator
Arm Description
Active Drug - Photocil for Psoriasis
Arm Title
Placebo - Sunscreen (SPF 2)
Arm Type
Placebo Comparator
Arm Description
Placebo - Sunscreen (SPF 2)
Intervention Type
Drug
Intervention Name(s)
Photocil for Psoriasis
Other Intervention Name(s)
Photocil for Psoriasis (U.S. FDA NDC: 54841-001-01)
Intervention Description
Photocil for Psoriasis
Intervention Type
Other
Intervention Name(s)
Placebo - Sunscreen (SPF 2)
Intervention Description
Placebo - Sunscreen (SPF 2)
Primary Outcome Measure Information:
Title
Percent Lesion Clearance
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with psoriasis vulgaris confirmed by a dermatologist
Psoriasis 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John McCoy, PhD
Organizational Affiliation
Applied Biology, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Physicians Institute
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Photocil (Topical) for the Treatment of Psoriasis Vulgaris
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