Evaluation of DD-25 Topical Cream for the Treatment of Psoriasis Vulgaris : Proof of Concept Study
NCT ID: NCT01702324
Last Updated: 2012-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2012-10-31
2013-09-30
Brief Summary
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The study will include subjects at plaque stage from 5-20% body area involvement. A total of 30 subjects will be treated with cream application on affected areas twice daily for three weeks.The efficacy of the preparation will be documented by PASI score, Global physician assessment and photos.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DD-25
A concentration of 0.025% of topical DD-25 cream.
DD-25
A topical DD-25 cream at 0.025% concentration.
Interventions
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DD-25
A topical DD-25 cream at 0.025% concentration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of PS by a dermatologist with lesions on arms, legs or trunk
3. Subjects have stable plaque PS, mild to moderate form, Body Surface Area of 5-20%.
4. Subject understood and signed an informed consent form
Exclusion Criteria
2. Hypersensitivity to sunlight; history of Lupus, PMLE, or any disease known to be worsened by UV light exposure
3. Pregnancy, breast feeding
4. History of cancer, excluding non-melanoma skin cancer.
5. Patients with history of ischemic heart disease (e.g. angina pectoris, myocardial infarction); cerebrovascular syndromes, peripheral vascular or uncontrolled hypertension. Subjects with known severe hepatic and/or severe renal insufficiency.
6. Any medical condition that, in the opinion of the Investigator, would jeopardize the health of the patient during the course of this study.
7. Systemic treatment with biological therapies with a possible effect on psoriasis vulgaris within 4 months or 5 drug half-lives prior to checkup.
8. Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immuno-suppressants) within the 8-week period prior to randomization. Subjects using within the 8 week period prior to randomization PUVA or Phototherapy. Use of SSRI or MAO inhibitors.
9. Subjects using one of the following TOPICAL drugs for the treatment of PS within 2 weeks prior to randomization: e.g. WHO group I-II corticosteroids, retinoids, Vit. D analogues, immunomodulators, Anthracene derivatives, Salicylic acid.
10. Subjects with current participation in any other interventional clinical or subjects with any concomitant dermatological disorder(s) which might preclude accurate evaluation of the psoriasis
18 Years
60 Years
ALL
No
Sponsors
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Fortuderm Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Hagit Matz, M.D.
Role: PRINCIPAL_INVESTIGATOR
Dept of Dermatology, Tel Aviv Sourasky Medical Center
Locations
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Tel Aviv Sourasky Medical Center
Tel Aviv, Tel Aviv, Israel
Countries
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Central Contacts
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Facility Contacts
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Dvora Krulfeld, M.A.
Role: primary
Other Identifiers
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0290-12-TLV
Identifier Type: OTHER
Identifier Source: secondary_id
DD-25
Identifier Type: -
Identifier Source: org_study_id