Atopic Dermatitis
Conditions
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.
Interventions
DRUGPhotocil for Atopic Dermatitis
Photocil for Atopic Dermatitis
Placebo - Sunscreen (SPF 2)
Sponsors
Applied Biology, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Pruritus Events in Last 30 Days | 30 days from baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Photocil for Atopic Dermatitis Active Drug - Photocil for Atopic Dermatitis
Photocil for Atopic Dermatitis: Photocil for Atopic Dermatitis | 7 |
| Placebo - Sunscreen (SPF 2) Placebo - Sunscreen (SPF 2)
Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2) | 0 |
| Total | 7 |
Baseline characteristics
| Characteristic | Total | Photocil for Atopic Dermatitis |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 7 Participants |
| Age, Continuous | 32.3 Years STANDARD_DEVIATION 5.29 | 32.3 Years STANDARD_DEVIATION 5.29 |
| Gender Female | 7 Participants | 7 Participants |
| Gender Male | 0 Participants | 0 Participants |
| Region of Enrollment United States | 7 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 7 | 0 / 0 |
| serious Total, serious adverse events | 0 / 7 | 0 / 0 |
Outcome results
Primary
Number of Pruritus Events in Last 30 Days
Time frame: 30 days from baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Photocil for Atopic Dermatitis | Number of Pruritus Events in Last 30 Days | Baseline | 7.4 Events | Standard Deviation 2.9 |
| Photocil for Atopic Dermatitis | Number of Pruritus Events in Last 30 Days | 90 Day | 1.9 Events | Standard Deviation 1.5 |