Photocil (Topical) for the Treatment of Atopic Dermatitis

Not Applicable

Completed

Interventions: Drug: Photocil for Atopic Dermatitis
Other: Placebo - Sunscreen (SPF 2)

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Photocil for Atopic Dermatitis	Photocil for Atopic Dermatitis	Active Drug - Photocil for Atopic Dermatitis
Placebo - Sunscreen (SPF 2)	Placebo - Sunscreen (SPF 2)	Placebo - Sunscreen (SPF 2)

Primary Outcome Measures