Photocil (Topical) for the Treatment of Vitiligo

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Applied Biology, Inc.
Sponsor:
Information provided by (Responsible Party):
Applied Biology, Inc.
ClinicalTrials.gov Identifier:
NCT01992185
First received: November 19, 2013
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Vitiligo
Drug: Photocil for Vitiligo
Other: Placebo - Sunscreen (SPF 2)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of Novel Topical Drug (Photocil) for the Treatment of Vitiligo

Resource links provided by NLM:


Further study details as provided by Applied Biology, Inc.:

Primary Outcome Measures:
  • Vitiligo Area Severity Index (VASI) [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Photocil for Vitiligo
Active Drug - Photocil for Vitiligo
Drug: Photocil for Vitiligo
Photocil for Vitiligo
Other Name: Photocil for Vitiligo (U.S. FDA NDC: 54841-001-01)
Placebo Comparator: Placebo - Sunscreen (SPF 2)
Placebo - Sunscreen (SPF 2)
Other: Placebo - Sunscreen (SPF 2)
Placebo - Sunscreen (SPF 2)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01992185

Contacts
Contact: Sharon Keene, MD (520) 290-5555

Locations
United States, Arizona
Physicians Institute Recruiting
Tucson, Arizona, United States, 85719
Contact: Sharon Keene, MD    520-290-5555      
Principal Investigator: Sharon Keene, MD         
Sponsors and Collaborators
Applied Biology, Inc.
Investigators
Study Director: John McCoy, PhD Applied Biology, Inc.
  More Information

No publications provided

Responsible Party: Applied Biology, Inc.
ClinicalTrials.gov Identifier: NCT01992185     History of Changes
Other Study ID Numbers: AB-DRUG-PHOTOCIL-VT-001
Study First Received: November 19, 2013
Last Updated: July 22, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases
Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 15, 2014