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

Primary Purpose

Psoriasis Vulgaris

Status

Unknown status

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

DD-25

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris focused on measuring Psoriasis Vulgaris, Plaque, Topical, Treatment

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject age 18-60
Diagnosis of PS by a dermatologist with lesions on arms, legs or trunk
Subjects have stable plaque PS, mild to moderate form, Body Surface Area of 5-20%.
Subject understood and signed an informed consent form

Exclusion Criteria:

Guttate, erythrodermic, palm-plantar or pustular psoriasis as sole or predominant form of psoriasis.
Hypersensitivity to sunlight; history of Lupus, PMLE, or any disease known to be worsened by UV light exposure
Pregnancy, breast feeding
History of cancer, excluding non-melanoma skin cancer.
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.
Any medical condition that, in the opinion of the Investigator, would jeopardize the health of the patient during the course of this study.
Systemic treatment with biological therapies with a possible effect on psoriasis vulgaris within 4 months or 5 drug half-lives prior to checkup.
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.
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.
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

Sites / Locations

Tel Aviv Sourasky Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DD-25

Arm Description

A concentration of 0.025% of topical DD-25 cream.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

PASI reduction of 50%

Full Information

NCT ID

NCT01702324

First Posted

October 3, 2012

Last Updated

October 4, 2012

Sponsor

Fortuderm Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01702324

Brief Title

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

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Unknown status

Study Start Date

October 2012 (undefined)

Primary Completion Date

August 2013 (Anticipated)

Study Completion Date

September 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fortuderm Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis Vulgaris

Keywords

Psoriasis Vulgaris, Plaque, Topical, Treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DD-25

Arm Type

Experimental

Arm Description

A concentration of 0.025% of topical DD-25 cream.

Intervention Type

Drug

Intervention Name(s)

DD-25

Other Intervention Name(s)

Fortuderm DD-25 Psoriasis Cream

Intervention Description

A topical DD-25 cream at 0.025% concentration.

Primary Outcome Measure Information:

Title

Efficacy after 3 weeks as compared to baseline.

Description

Time Frame

3 weeks

Secondary Outcome Measure Information:

Title

PASI reduction of 50%

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject age 18-60 Diagnosis of PS by a dermatologist with lesions on arms, legs or trunk Subjects have stable plaque PS, mild to moderate form, Body Surface Area of 5-20%. Subject understood and signed an informed consent form Exclusion Criteria: Guttate, erythrodermic, palm-plantar or pustular psoriasis as sole or predominant form of psoriasis. Hypersensitivity to sunlight; history of Lupus, PMLE, or any disease known to be worsened by UV light exposure Pregnancy, breast feeding History of cancer, excluding non-melanoma skin cancer. 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. Any medical condition that, in the opinion of the Investigator, would jeopardize the health of the patient during the course of this study. Systemic treatment with biological therapies with a possible effect on psoriasis vulgaris within 4 months or 5 drug half-lives prior to checkup. 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. 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. 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Avi Dascalu, M.D., Ph.D.

Phone

972-3-6099005

dasc01@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hagit Matz, M.D.

Organizational Affiliation

Dept of Dermatology, Tel Aviv Sourasky Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tel Aviv Sourasky Medical Center

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dvora Krulfeld, M.A.

Phone

97236973768

dvoray@tasmc.health.gov.il

First Name & Middle Initial & Last Name & Degree

Hagit Matz, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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