Trial record 12 of 23 for:    Open Studies | "Vitiligo"

Photocil (Topical) for the Treatment of Vitiligo

This study is currently recruiting participants.
Verified November 2013 by Applied Biology, Inc.
Sponsor:
Information provided by (Responsible Party):
Applied Biology, Inc.
ClinicalTrials.gov Identifier:
NCT01992185
First received: November 19, 2013
Last updated: November 22, 2013
Last verified: November 2013
  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
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: November 22, 2013
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 April 17, 2014