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

Psoriasis Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01702324
• Other study ID #: DD-25
• Secondary ID: 0290-12-TLV
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: October 3, 2012
• Last updated: October 4, 2012
• Start date: October 2012
• Est. completion date: September 2013

Study information

• Verified date: October 2012
• Source: Fortuderm Ltd.
• Contact: Avi Dascalu, M.D., Ph.D.
• Phone: 972-3-6099005
• Email: dasc01[@]yahoo.com
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• DD-25
A topical DD-25 cream at 0.025% concentration.

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Fortuderm Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	PASI reduction of 50%		3 weeks	No