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

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.

Study Overview

• Status: Unknown
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Drug: DD-25

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel, 64239
    • Recruiting
    • Tel Aviv Sourasky Medical Center
    • Contact: Dvora Krulfeld, M.A.; Phone Number: 97236973768; Email: dvoray@tasmc.health.gov.il
    • Principal Investigator: Hagit Matz, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Fortuderm DD-25 Psoriasis Cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy after 3 weeks as compared to baseline.	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.	3 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
PASI reduction of 50%	3 weeks

Collaborators and Investigators

• Sponsor: Fortuderm Ltd.
• Investigators: Principal Investigator: Hagit Matz, M.D., Dept of Dermatology, Tel Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ANTICIPATED): August 1, 2013
• Study Completion (ANTICIPATED): September 1, 2013

Study Registration Dates

• First Submitted: October 3, 2012
• First Submitted That Met QC Criteria: October 4, 2012
• First Posted (ESTIMATE): October 8, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 8, 2012
• Last Update Submitted That Met QC Criteria: October 4, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Treatment; Psoriasis Vulgaris; Topical; Plaque
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: DD-25; 0290-12-TLV (OTHER: Tel Aviv Sourasky Medical Center)