- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01992172
Photocil (Topical) for the Treatment of Atopic Dermatitis
Pilot Study of Novel Topical Drug (Photocil) for the Treatment of Atopic Dermatitis
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Arizona
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Tucson, Arizona, United States, 85719
- Physicians Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Photocil for Atopic Dermatitis
Active Drug - Photocil for Atopic Dermatitis
|
Photocil for Atopic Dermatitis
Other Names:
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PLACEBO_COMPARATOR: Placebo - Sunscreen (SPF 2)
|
Placebo - Sunscreen (SPF 2)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Pruritus Events in Last 30 Days
Time Frame: 30 days from baseline
|
30 days from baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Genetic Diseases, Inborn
- Skin Diseases, Genetic
- Hypersensitivity
- Skin Diseases, Eczematous
- Dermatitis
- Eczema
- Dermatitis, Atopic
- Physiological Effects of Drugs
- Protective Agents
- Dermatologic Agents
- Radiation-Protective Agents
- Sunscreening Agents
Other Study ID Numbers
- AB-DRUG-PHOTOCIL-AD-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atopic Dermatitis
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Catalysis SLCompletedAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis and Related Conditions | Atopic Dermatitis \(AD\)Serbia
-
Jacob Pontoppidan ThyssenThe Novo Nordic FoundationRecruitingAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis FlareDenmark
-
ShaperonNot yet recruitingAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis of Scalp
-
University of California, San FranciscoSanofi; Regeneron PharmaceuticalsRecruitingEczema | Atopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis and Related ConditionsUnited States
-
PfizerActive, not recruitingEczema | Atopic Dermatitis | Eczema, Atopic | Atopic Dermatitis, UnspecifiedUnited States, Canada, Czechia, Poland
-
AmgenCompletedDermatitis, Atopic DermatitisCanada, United States, Japan
-
SanofiCompletedAtopic Dermatitis | Dermatitis AtopicChina
-
SanofiCompletedDermatitis AtopicSaudi Arabia, Kuwait, United Arab Emirates
-
Hadassah Medical OrganizationUnknownATOPIC DERMATITIS
-
Regeneron PharmaceuticalsSanofiRecruitingModerate-to-Severe Atopic Dermatitis | Atopic EczemaUnited States
Clinical Trials on Placebo - Sunscreen (SPF 2)
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Sun Protection FoundationEnrolling by invitationSunburn | Sun Damaged Skin | Overexposure to Sun RaysUnited States, Chile, Peru
-
Johnson & Johnson Consumer Inc. (J&JCI)Completed
-
Universidade do Vale do SapucaiCompleted
-
BayerCompleted
-
Applied Biology, Inc.Completed
-
Applied Biology, Inc.Completed
-
GlaxoSmithKlineCompleted
-
BayerCompletedSunscreening AgentsUnited States
-
ISDINUnknownActinic KeratosisItaly
-
Revision SkincareAblon Skin Institute Research CenterCompletedWrinkles | Photoaging | Fine LinesUnited States