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Photocil (Topical) for the Treatment of Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Photocil for Atopic Dermatitis
Placebo - Sunscreen (SPF 2)
Sponsored by
Applied Biology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with atopic dermatitis confirmed by a dermatologist
  • Atopic dermatitis 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

Sites / Locations

  • Physicians Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Photocil for Atopic Dermatitis

Placebo - Sunscreen (SPF 2)

Arm Description

Active Drug - Photocil for Atopic Dermatitis

Placebo - Sunscreen (SPF 2)

Outcomes

Primary Outcome Measures

Number of Pruritus Events in Last 30 Days

Secondary Outcome Measures

Full Information

First Posted
November 19, 2013
Last Updated
February 25, 2016
Sponsor
Applied Biology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01992172
Brief Title
Photocil (Topical) for the Treatment of Atopic Dermatitis
Official Title
Pilot Study of Novel Topical Drug (Photocil) for the Treatment of Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Applied Biology, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 atopic dermatitis.
Detailed Description
NB-UVB phototherapy is a common treatment for patients with atopic dermatitis, and has been reported to be safe and effective in numerous clinical trials. Clinical trials have reported achievement of Atopic Dermatitis Area Severity Index (ADASI)-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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Photocil for Atopic Dermatitis
Arm Type
Active Comparator
Arm Description
Active Drug - Photocil for Atopic Dermatitis
Arm Title
Placebo - Sunscreen (SPF 2)
Arm Type
Placebo Comparator
Arm Description
Placebo - Sunscreen (SPF 2)
Intervention Type
Drug
Intervention Name(s)
Photocil for Atopic Dermatitis
Other Intervention Name(s)
Photocil for Atopic Dermatitis (U.S. FDA NDC: 54841-001-01)
Intervention Description
Photocil for Atopic Dermatitis
Intervention Type
Other
Intervention Name(s)
Placebo - Sunscreen (SPF 2)
Intervention Description
Placebo - Sunscreen (SPF 2)
Primary Outcome Measure Information:
Title
Number of Pruritus Events in Last 30 Days
Time Frame
30 days from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with atopic dermatitis confirmed by a dermatologist Atopic dermatitis 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John McCoy, PhD
Organizational Affiliation
Applied Biology, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Physicians Institute
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Photocil (Topical) for the Treatment of Atopic Dermatitis

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