Investigation of the Efficacy of 2.5% and 5% Cis-urocanic Acid in Patients With Moderate or Severe Atopic Dermatitis

June 20, 2012 updated by: BioCis Pharma Ltd

Phase II Study to Investigate the Properties of Topical Twice Daily Doses of 2.5% and 5% Cis-urocanic Acid in Comparison to Active Comparator 0.1% Protopic® for up to 28 Days in Patients With Moderate or Severe Atopic Dermatitis

The purpose of this study is to evaluate dose response, safety, tolerability and efficacy of 2.5% and 5% cis-UCA in comparison to placebo and active comparator in the treatment of adult patients with moderate or severe chronic atopic dermatitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a Phase II multi-centre, double-blinded, vehicle-controlled, repeated and multiple dose, study to evaluate dose response, safety, tolerability and efficacy of 2.5% and 5% cis-UCA compared to placebo, and investigator-blinded to compare the safety, tolerability and efficacy of cis-UCA to the active comparator Protopic® 0.1% in patients with moderate or severe chronic atopic dermatitis treated for up to 28 days.

The primary objective is to compare the efficacy of two different doses of cis-UCA (2.5% and 5%) with placebo for up to 28 days in adult patients with moderate or severe chronic atopic dermatitis to determine the dose of cis-UCA for further clinical development.

Secondary objectives are as follows:

  • To evaluate safety and tolerability of cis-UCA after topical twice daily doses of 2.5% and 5% for up to 28 days in adult patients with moderate or severe chronic atopic dermatitis.
  • To evaluate dose response after topical twice daily doses of 2.5% and 5% for up to 28 days in adult subjects with moderate or severe chronic atopic dermatitis.
  • To compare the efficacy and safety of 2.5% and 5% of cis-UCA to the efficacy and safety of 0.1% Protopic® after topical twice daily doses for up to 28 days in adult patients with moderate or severe chronic atopic dermatitis

The key eligibility criteria are the following: patients with moderate or severe chronic atopic dermatitis, at least 18 years of age, with no current treatment for atopic dermatitis with active systemic medication or active topical treatment in the planned investigational area, and with no history of any significant disease that would affect the use of cis-UCA or comparator.

In total, up to 150 adult patients (both males and females; at least 20% of each gender) with moderate or severe chronic atopic dermatitis will be included in the study. Up to 36 adult patients (both males and females) will be included in each treatment arm.

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00200
        • Helsinki University Central Hospital, Skin and Allergy Hospital
      • Kuopio, Finland
        • Mehiläinen Medical Center Kuopio
      • Lohja, Finland
        • Lohja Hospital, Clinic of Dermatology and Allergology
      • Tampere, Finland, FI-33520
        • FinnMedi Oy
      • Turku, Finland
        • Mehiläinen Medical Center Turku
      • Turku, Finland
        • Pulssi Medical Center
      • Turku, Finland
        • Turku University Hospital, Department of Dermatology and Venereal Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent obtained prior to any screening procedure
  • Caucasian male or female patient
  • At least 18 years of age
  • Weight at least 45 kg
  • Patient with moderate or severe chronic atopic dermatitis
  • Good general health ascertained by medical history, physical examination and laboratory determinations, showing no signs of clinically significant findings, except chronic atopic dermatitis
  • Negative pregnancy test (premenopausal female patient) at screening and use of adequate contraceptive measures (both male and female patients) throughout the study and 30 days after the last cis-UCA dose

Exclusion Criteria:

  • History of other significant skin disease, or skin manifestations of allergic illness or other dermatologic condition, except chronic moderate or severe atopic dermatitis, that would interfere with the trial assessments or compromise the patient's safety according to the opinion of the Investigator
  • Present symptoms of other skin diseases, except chronic atopic dermatitis, that could disturb the study assessment and evaluation of the skin
  • Current use of any active systemic medication for chronic atopic dermatitis within one month
  • Current use of active topical medication in the planned investigational area for chronic atopic dermatitis within two weeks
  • History of a sunny holiday, UV-light therapy or solarium use within one month before beginning of study treatments, or planning such during the study or within 7 days after the study
  • Allergy to cis-UCA, or any constituents of the placebo emulsion cream or any constituents of Protopic® ointment
  • History of any skin-related cancer
  • Congenital or acquired immunodeficiency or ongoing therapy that cause immunosuppression
  • Earlier participation in a clinical study performed with cis-UCA
  • Any clinically significant laboratory test result
  • Suspected current drug or alcohol abuse
  • Clinically significant illness during the 4 weeks prior to the first dose administration
  • Any other condition that in the opinion of the Investigator would interfere with the evaluation of the study results or constitute a health hazard for the patient
  • Unwillingness or doubtful capacity to comply with the protocol
  • Doubtful availability to complete the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 2 Cis-UCA 5% emulsion cream
Drug: Cis-UCA 5% emulsion cream
5% cis-UCA in emulsion cream base twice daily, amount of a fingertip per one hand (i.e. palm + thumb + fingers) area, applied topically as a thin layer on the affected skin area of approximate size of maximally three hand areas for up to 28 days (one fingertip per one hand area)
Other Names:
  • Cis-UCA 5%
Placebo Comparator: Group 3 Placebo cis-UCA emulsion cream
Drug: Placebo for cis-UCA emulsion cream
The placebo for cis-UCA product (emulsion cream base) twice daily, amount of a fingertip per one hand area applied topically as a thin layer on the affected skin area on of approximate size of maximally three hand areas for up to 28 days (one fingertip per one hand area).
Other Names:
  • Placebo
Active Comparator: Group 4 Protopic® 0.1% ointment
Drug: Protopic® 0.1% ointment
0.1% Protopic® twice daily, amount of a fingertip per one hand area applied topically as a thin layer on the affected skin area of approximate size of maximally three hand areas for up to 28 days (one fingertip per one hand area).
Other Names:
  • Protopic®
Experimental: Group 1 Cis-UCA 2.5% emulsion cream
Drug: Cis-UCA 2.5% emulsion cream
2.5% cis-UCA in emulsion cream base twice daily, amount of a fingertip per one hand (i.e. palm + thumb + fingers) area, applied topically as a thin layer on the affected skin area of approximate size of maximally three hand areas for up to 28 days (one fingertip per one hand area)
Other Names:
  • Cis-UCA 2.5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical Skin Assessment of erythema, oedema/papulation, oozing/crusts, excoriations, and lichenification
Time Frame: 37 days
37 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Skin Erythema measurement
Time Frame: 37 days
37 days
Transepidermal Water Loss (TEWL) measurement
Time Frame: 37 days
37 days
Visual Analogue Scale (VAS) assessment for itching (pruritus) of the treatment area
Time Frame: 37 days
37 days
Physician Global Assessment (PGA)
Time Frame: 37 days
37 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioCis Pharma Ltd

Investigators

  • Principal Investigator: Sakari Reitamo, Professor, Helsinki University Central Hospital, Skin and Allergy Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

March 21, 2011

First Submitted That Met QC Criteria

March 21, 2011

First Posted (Estimate)

March 22, 2011

Study Record Updates

Last Update Posted (Estimate)

June 21, 2012

Last Update Submitted That Met QC Criteria

June 20, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL09002
  • 2010-023543-15 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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