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Photocil (Topical) for the Treatment of Vitiligo

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01992185
First Posted: November 25, 2013
Last Update Posted: March 10, 2016
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.
Information provided by (Responsible Party):
Applied Biology, Inc.
  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: Quadruple (Participant, Care Provider, 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:
  • Percent Repigmentation [ Time Frame: 90 days ]

Enrollment: 15
Study Start Date: August 2013
Study Completion Date: December 2014
Primary Completion Date: December 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992185


Locations
United States, Arizona
Physicians Institute
Tucson, Arizona, United States, 85719
Sponsors and Collaborators
Applied Biology, Inc.
Investigators
Study Director: John McCoy, PhD Applied Biology, Inc.
  More Information

Responsible Party: Applied Biology, Inc.
ClinicalTrials.gov Identifier: NCT01992185     History of Changes
Other Study ID Numbers: AB-DRUG-PHOTOCIL-VT-001
First Submitted: November 19, 2013
First Posted: November 25, 2013
Results First Submitted: December 11, 2015
Results First Posted: March 10, 2016
Last Update Posted: March 10, 2016
Last Verified: February 2016

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