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Photocil (Topical) for the Treatment of Vitiligo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01992185
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : March 10, 2016
Last Update Posted : March 10, 2016
Sponsor:
Information provided by (Responsible Party):
Applied Biology, Inc.

Tracking Information
First Submitted Date  ICMJE November 19, 2013
First Posted Date  ICMJE November 25, 2013
Results First Submitted Date  ICMJE December 11, 2015
Results First Posted Date  ICMJE March 10, 2016
Last Update Posted Date March 10, 2016
Study Start Date  ICMJE August 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2016)
Percent Repigmentation [ Time Frame: 90 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 22, 2013)
Vitiligo Area Severity Index (VASI) [ Time Frame: 90 days ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Photocil (Topical) for the Treatment of Vitiligo
Official Title  ICMJE Pilot Study of Novel Topical Drug (Photocil) for the Treatment of Vitiligo
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 vitiligo.
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 Vitiligo Area Severity Index (VASI)-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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Vitiligo
Intervention  ICMJE
  • Drug: Photocil for Vitiligo
    Photocil for Vitiligo
    Other Name: Photocil for Vitiligo (U.S. FDA NDC: 54841-001-01)
  • Other: Placebo - Sunscreen (SPF 2)
    Placebo - Sunscreen (SPF 2)
Study Arms  ICMJE
  • Active Comparator: Photocil for Vitiligo
    Active Drug - Photocil for Vitiligo
    Intervention: Drug: Photocil for Vitiligo
  • Placebo Comparator: Placebo - Sunscreen (SPF 2)
    Placebo - Sunscreen (SPF 2)
    Intervention: Other: Placebo - Sunscreen (SPF 2)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2016)
15
Original Estimated Enrollment  ICMJE
 (submitted: November 22, 2013)
50
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01992185
Other Study ID Numbers  ICMJE AB-DRUG-PHOTOCIL-VT-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Applied Biology, Inc.
Study Sponsor  ICMJE Applied Biology, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: John McCoy, PhD Applied Biology, Inc.
PRS Account Applied Biology, Inc.
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP