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Trial record 30 of 838 for:    eczema

Photocil (Topical) for the Treatment of Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT01992172
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : March 25, 2016
Last Update Posted : March 25, 2016
Sponsor:
Information provided by (Responsible Party):
Applied Biology, Inc.

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Photocil for Atopic Dermatitis Other: Placebo - Sunscreen (SPF 2) Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
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 Atopic Dermatitis
Study Start Date : August 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Sun Exposure

Arm Intervention/treatment
Active Comparator: Photocil for Atopic Dermatitis
Active Drug - Photocil for Atopic Dermatitis
Drug: Photocil for Atopic Dermatitis
Photocil for Atopic Dermatitis
Other Name: Photocil for Atopic Dermatitis (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)




Primary Outcome Measures :
  1. Number of Pruritus Events in Last 30 Days [ Time Frame: 30 days from baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT01992172


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.

Responsible Party: Applied Biology, Inc.
ClinicalTrials.gov Identifier: NCT01992172     History of Changes
Other Study ID Numbers: AB-DRUG-PHOTOCIL-AD-001
First Posted: November 25, 2013    Key Record Dates
Results First Posted: March 25, 2016
Last Update Posted: March 25, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Eczema
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Dermatologic Agents