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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BioCis Pharma Ltd
ClinicalTrials.gov Identifier:
NCT01320579
First received: March 21, 2011
Last updated: June 20, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Atopic Dermatitis
Drug: Cis-UCA 2.5% emulsion cream
Drug: Cis-UCA 5% emulsion cream
Drug: Placebo for cis-UCA emulsion cream
Drug: Protopic® 0.1% ointment
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by BioCis Pharma Ltd:

Primary Outcome Measures:
  • Clinical Skin Assessment of erythema, oedema/papulation, oozing/crusts, excoriations, and lichenification [ Time Frame: 37 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Skin Erythema measurement [ Time Frame: 37 days ] [ Designated as safety issue: No ]
  • Transepidermal Water Loss (TEWL) measurement [ Time Frame: 37 days ] [ Designated as safety issue: No ]
  • Visual Analogue Scale (VAS) assessment for itching (pruritus) of the treatment area [ Time Frame: 37 days ] [ Designated as safety issue: No ]
  • Physician Global Assessment (PGA) [ Time Frame: 37 days ] [ Designated as safety issue: No ]

Enrollment: 159
Study Start Date: March 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: Cis-UCA 2.5%

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01320579

Locations
Finland
Helsinki University Central Hospital, Skin and Allergy Hospital
Helsinki, Finland, 00200
Mehiläinen Medical Center Kuopio
Kuopio, Finland
Lohja Hospital, Clinic of Dermatology and Allergology
Lohja, Finland
FinnMedi Oy
Tampere, Finland, FI-33520
Pulssi Medical Center
Turku, Finland
Turku University Hospital, Department of Dermatology and Venereal Diseases
Turku, Finland
Mehiläinen Medical Center Turku
Turku, Finland
Sponsors and Collaborators
BioCis Pharma Ltd
Investigators
Principal Investigator: Sakari Reitamo, Professor Helsinki University Central Hospital, Skin and Allergy Hospital
  More Information

Publications:
Responsible Party: BioCis Pharma Ltd
ClinicalTrials.gov Identifier: NCT01320579     History of Changes
Other Study ID Numbers: CL09002, 2010-023543-15
Study First Received: March 21, 2011
Last Updated: June 20, 2012
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by BioCis Pharma Ltd:
atopic dermatitis
cis-urocanic acid

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014