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

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 2

Locations

Finland

Study Type

Interventional

Intervention

Cis-UCA 2.5% emulsion cream

Cis-UCA 5% emulsion cream

Placebo for cis-UCA emulsion cream

Protopic® 0.1% ointment

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring atopic dermatitis, cis-urocanic acid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Helsinki University Central Hospital, Skin and Allergy Hospital
Mehiläinen Medical Center Kuopio
Lohja Hospital, Clinic of Dermatology and Allergology
FinnMedi Oy
Mehiläinen Medical Center Turku
Pulssi Medical Center
Turku University Hospital, Department of Dermatology and Venereal Diseases

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Active Comparator

Experimental

Arm Label

Group 2 Cis-UCA 5% emulsion cream

Group 3 Placebo cis-UCA emulsion cream

Group 4 Protopic® 0.1% ointment

Group 1 Cis-UCA 2.5% emulsion cream

Arm Description

Outcomes

Primary Outcome Measures

Clinical Skin Assessment of erythema, oedema/papulation, oozing/crusts, excoriations, and lichenification

Secondary Outcome Measures

Skin Erythema measurement

Transepidermal Water Loss (TEWL) measurement

Visual Analogue Scale (VAS) assessment for itching (pruritus) of the treatment area

Physician Global Assessment (PGA)

Full Information

NCT ID

NCT01320579

First Posted

March 21, 2011

Last Updated

June 20, 2012

Sponsor

BioCis Pharma Ltd

1. Study Identification

Unique Protocol Identification Number

NCT01320579

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

BioCis Pharma Ltd

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

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

Atopic Dermatitis

Keywords

atopic dermatitis, cis-urocanic acid

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

159 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 2 Cis-UCA 5% emulsion cream

Arm Type

Experimental

Arm Title

Group 3 Placebo cis-UCA emulsion cream

Arm Type

Placebo Comparator

Arm Title

Group 4 Protopic® 0.1% ointment

Arm Type

Active Comparator

Arm Title

Group 1 Cis-UCA 2.5% emulsion cream

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Cis-UCA 2.5% emulsion cream

Other Intervention Name(s)

Cis-UCA 2.5%

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

Cis-UCA 5% emulsion cream

Other Intervention Name(s)

Cis-UCA 5%

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

Placebo for cis-UCA emulsion cream

Other Intervention Name(s)

Placebo

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Protopic® 0.1% ointment

Other Intervention Name(s)

Protopic®

Intervention Description

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).

Primary Outcome Measure Information:

Title

Clinical Skin Assessment of erythema, oedema/papulation, oozing/crusts, excoriations, and lichenification

Time Frame

37 days

Secondary Outcome Measure Information:

Title

Skin Erythema measurement

Time Frame

37 days

Title

Transepidermal Water Loss (TEWL) measurement

Time Frame

37 days

Title

Visual Analogue Scale (VAS) assessment for itching (pruritus) of the treatment area

Time Frame

37 days

Title

Physician Global Assessment (PGA)

Time Frame

37 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sakari Reitamo, Professor

Organizational Affiliation

Helsinki University Central Hospital, Skin and Allergy Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Helsinki University Central Hospital, Skin and Allergy Hospital

City

Helsinki

ZIP/Postal Code

00200

Country

Finland

Facility Name

Mehiläinen Medical Center Kuopio

City

Kuopio

Country

Finland

Facility Name

Lohja Hospital, Clinic of Dermatology and Allergology

City

Lohja

Country

Finland

Facility Name

FinnMedi Oy

City

Tampere

ZIP/Postal Code

FI-33520

Country

Finland

Facility Name

Mehiläinen Medical Center Turku

City

Turku

Country

Finland

Facility Name

Pulssi Medical Center

City

Turku

Country

Finland

Facility Name

Turku University Hospital, Department of Dermatology and Venereal Diseases

City

Turku

Country

Finland

12. IPD Sharing Statement

Citations:

PubMed Identifier

18385500

Citation

Bieber T. Atopic dermatitis. N Engl J Med. 2008 Apr 3;358(14):1483-94. doi: 10.1056/NEJMra074081. No abstract available.

Results Reference

background

PubMed Identifier

19494826

Citation

Cork MJ, Danby SG, Vasilopoulos Y, Hadgraft J, Lane ME, Moustafa M, Guy RH, Macgowan AL, Tazi-Ahnini R, Ward SJ. Epidermal barrier dysfunction in atopic dermatitis. J Invest Dermatol. 2009 Aug;129(8):1892-908. doi: 10.1038/jid.2009.133. Epub 2009 Jun 4.

Results Reference

background

PubMed Identifier

6223114

Citation

De Fabo EC, Noonan FP. Mechanism of immune suppression by ultraviolet irradiation in vivo. I. Evidence for the existence of a unique photoreceptor in skin and its role in photoimmunology. J Exp Med. 1983 Jul 1;158(1):84-98. doi: 10.1084/jem.158.1.84.

Results Reference

background

PubMed Identifier

8435513

Citation

Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology. 1993;186(1):23-31. doi: 10.1159/000247298.

Results Reference

background

PubMed Identifier

17498413

Citation

Hanifin JM, Reed ML; Eczema Prevalence and Impact Working Group. A population-based survey of eczema prevalence in the United States. Dermatitis. 2007 Jun;18(2):82-91. doi: 10.2310/6620.2007.06034.

Results Reference

background

PubMed Identifier

2800895

Citation

Rajka G, Langeland T. Grading of the severity of atopic dermatitis. Acta Derm Venereol Suppl (Stockh). 1989;144:13-4. doi: 10.2340/000155551441314.

Results Reference

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PubMed Identifier

10494710

Citation

Wolkerstorfer A, de Waard van der Spek FB, Glazenburg EJ, Mulder PG, Oranje AP. Scoring the severity of atopic dermatitis: three item severity score as a rough system for daily practice and as a pre-screening tool for studies. Acta Derm Venereol. 1999 Sep;79(5):356-9. doi: 10.1080/000155599750010256.

Results Reference

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PubMed Identifier

24284985

Citation

Peltonen JM, Pylkkanen L, Jansen CT, Volanen I, Lehtinen T, Laihia JK, Leino L. Three randomised phase I/IIa trials of 5% cis-urocanic acid emulsion cream in healthy adult subjects and in patients with atopic dermatitis. Acta Derm Venereol. 2014 Jul;94(4):415-20. doi: 10.2340/00015555-1735.

Results Reference

derived

Learn more about this trial

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

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