NCT01702324

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 8, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

October 8, 2012

Status Verified

October 1, 2012

Enrollment Period

10 months

First QC Date

October 3, 2012

Last Update Submit

October 4, 2012

Conditions

Psoriasis Vulgaris

Keywords

Psoriasis VulgarisPlaqueTopicalTreatment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • PASI reduction of 50%

    3 weeks

Study Arms (1)

DD-25

EXPERIMENTAL

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

Drug: DD-25

Interventions

DD-25DRUG

A topical DD-25 cream at 0.025% concentration.

Also known as: Fortuderm DD-25 Psoriasis Cream
DD-25

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, Tel Aviv, 64239, Israel

RECRUITING

MeSH Terms

Conditions

Plaque, Amyloid

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Hagit Matz, M.D.

    Dept of Dermatology, Tel Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

972-3-6099005dasc01@yahoo.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2012

First Posted

October 8, 2012

Study Start

October 1, 2012

Primary Completion

August 1, 2013

Study Completion

September 1, 2013

Last Updated

October 8, 2012

Record last verified: 2012-10

Locations

IL(1)