Photocil (Topical) for the Treatment of Vitiligo

NCT ID: NCT01992185

Last Updated: 2016-03-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Vitiligo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Photocil for Vitiligo

Active Drug - Photocil for Vitiligo

Group Type ACTIVE_COMPARATOR

Photocil for Vitiligo

Intervention Type DRUG

Photocil for Vitiligo

Placebo - Sunscreen (SPF 2)

Placebo - Sunscreen (SPF 2)

Group Type PLACEBO_COMPARATOR

Placebo - Sunscreen (SPF 2)

Intervention Type OTHER

Placebo - Sunscreen (SPF 2)

Interventions

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Photocil for Vitiligo

Photocil for Vitiligo

Intervention Type DRUG

Placebo - Sunscreen (SPF 2)

Placebo - Sunscreen (SPF 2)

Intervention Type OTHER

Other Intervention Names

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Photocil for Vitiligo (U.S. FDA NDC: 54841-001-01)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Applied Biology, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John McCoy, PhD

Role: STUDY_DIRECTOR

Applied Biology, Inc.

Locations

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Physicians Institute

Tucson, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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AB-DRUG-PHOTOCIL-VT-001

Identifier Type: -

Identifier Source: org_study_id

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