Photocil (Topical) for the Treatment of Atopic Dermatitis
| Status: | Completed |
|---|---|
| Conditions: | Psoriasis, Dermatology, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | August 2013 |
| End Date: | December 2014 |
Pilot Study of Novel Topical Drug (Photocil) for the Treatment of Atopic Dermatitis
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.
(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.
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.
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.
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
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