Photocil (Topical) for the Treatment of Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

Pilot Study of Novel Topical Drug (Photocil) for the Treatment of Atopic Dermatitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01992172
• Other study ID #: AB-DRUG-PHOTOCIL-AD-001
• Status: Recruiting
• Phase: N/A
• First received: November 19, 2013
• Last updated: July 21, 2014
• Start date: August 2013
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Applied Biology, Inc.
• Contact: Sharon Keene, MD
• Phone: (520) 290-5555
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Photocil for Atopic Dermatitis
Photocil for Atopic Dermatitis

Other:
• Placebo - Sunscreen (SPF 2)
Placebo - Sunscreen (SPF 2)

Locations

Country	Name	City	State
United States	Physicians Institute	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Applied Biology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atopic Dermatitis Area Severity Index (ADASI)		90 days	No