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Evaluation of DD-25 Topical Cream for the Treatment of Psoriasis Vulgaris : Proof of Concept Study

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ClinicalTrials.gov Identifier: NCT01702324
Recruitment Status : Unknown
Verified October 2012 by Fortuderm Ltd..
Recruitment status was:  Recruiting
First Posted : October 8, 2012
Last Update Posted : October 8, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Drug: DD-25 Phase 1 Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of DD-25 Topical Cream for the Treatment of Psoriasis Vulgaris : Proof of Concept Study
Study Start Date : October 2012
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: DD-25
A concentration of 0.025% of topical DD-25 cream.
Drug: DD-25
A topical DD-25 cream at 0.025% concentration.
Other Name: Fortuderm DD-25 Psoriasis Cream


Outcome Measures

Primary Outcome Measures :
  1. Efficacy after 3 weeks as compared to baseline. [ Time Frame: 3 weeks ]
    Evaluation of the effectiveness of DD-25 over a period of 3 weeks treatment by analyzing the changes in the Psoriasis Area & Severity Index (PASI) in moderate to mild Plaque Psoriasis patients. Improvement to be assessed by changes in erythema, induration and desquamation as seen on days 0, 10 and 21.


Secondary Outcome Measures :
  1. PASI reduction of 50% [ Time Frame: 3 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01702324


Contacts
Contact: Avi Dascalu, M.D., Ph.D. 972-3-6099005 dasc01@yahoo.com

Locations
Israel
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Contact: Dvora Krulfeld, M.A.    97236973768    dvoray@tasmc.health.gov.il   
Principal Investigator: Hagit Matz, M.D.         
Sponsors and Collaborators
Fortuderm Ltd.
Investigators
Principal Investigator: Hagit Matz, M.D. Dept of Dermatology, Tel Aviv Sourasky Medical Center
More Information

Responsible Party: Fortuderm Ltd.
ClinicalTrials.gov Identifier: NCT01702324     History of Changes
Other Study ID Numbers: DD-25
0290-12-TLV ( Other Identifier: Tel Aviv Sourasky Medical Center )
First Posted: October 8, 2012    Key Record Dates
Last Update Posted: October 8, 2012
Last Verified: October 2012

Keywords provided by Fortuderm Ltd.:
Psoriasis Vulgaris
Plaque
Topical
Treatment

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases