Clinical trial NCT01702324: Evaluation of DD-25 Topical Cream for the Treatment of Psoriasis Vulgaris : Proof of Concept Study
Official title: Evaluation of DD-25 Topical Cream for the Treatment of Psoriasis Vulgaris : Proof of Concept Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Psoriasis Vulgaris
Keywords: Psoriasis Vulgaris
Plaque
Topical
Treatment
Lead sponsor: Fortuderm Ltd.
Sponsor class: INDUSTRY
First posted: 2012-10-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy of DD-25, a new topical drug, on plaque Psoriasis Vulgaris.

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: Psoriasis Vulgaris remains a widespread clinical entity with chronic outflares and various regimens of treatment, none of them definitive. A new safe and efficacious, external treatment is required for.

Eligibility criteria: Inclusion Criteria:

1. Subject age 18-60
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:

1. Guttate, erythrodermic, palm-plantar or pustular psoriasis as sole or predominant form of psoriasis.
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

Primary outcomes:
measure: Efficacy after 3 weeks as compared to baseline.
timeFrame: 3 weeks
Secondary outcomes:
measure: PASI reduction of 50%
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
affiliation: Dept of Dermatology, Tel Aviv Sourasky Medical Center
name: Hagit Matz, M.D.
role: PRINCIPAL_INVESTIGATOR
References: