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

NCT01320579 | Completed Phase 2

• 2 other identifiers: CL090022010-023543-15
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 7

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.

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis; cis-urocanic acid

Outcome Measures

Primary Outcomes (1)

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

  37 days

Secondary Outcomes (4)

• Skin Erythema measurement

  37 days

• Transepidermal Water Loss (TEWL) measurement

  37 days

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

  37 days

• Physician Global Assessment (PGA)

  37 days

Study Arms (4)

Group 2 Cis-UCA 5% emulsion cream

EXPERIMENTAL

Drug: Cis-UCA 5% emulsion cream

Group 3 Placebo cis-UCA emulsion cream

PLACEBO COMPARATOR

Drug: Placebo for cis-UCA emulsion cream

Group 4 Protopic® 0.1% ointment

ACTIVE COMPARATOR

Drug: Protopic® 0.1% ointment

Group 1 Cis-UCA 2.5% emulsion cream

EXPERIMENTAL

Drug: Cis-UCA 2.5% emulsion cream

Interventions

Cis-UCA 2.5% emulsion cream DRUG

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)

Also known as: Cis-UCA 2.5%

Group 1 Cis-UCA 2.5% emulsion cream

Cis-UCA 5% emulsion cream DRUG

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)

Also known as: Cis-UCA 5%

Group 2 Cis-UCA 5% emulsion cream

Placebo for cis-UCA emulsion cream DRUG

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).

Also known as: Placebo

Group 3 Placebo cis-UCA emulsion cream

Protopic® 0.1% ointment DRUG

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).

Also known as: Protopic®

Group 4 Protopic® 0.1% ointment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioCis Pharma Ltd: lead

Study Sites (7)

Helsinki University Central Hospital, Skin and Allergy Hospital

Helsinki, 00200, Finland

Location

Mehiläinen Medical Center Kuopio

Kuopio, Finland

Location

Lohja Hospital, Clinic of Dermatology and Allergology

Lohja, Finland

Location

FinnMedi Oy

Tampere, FI-33520, Finland

Location

Mehiläinen Medical Center Turku

Turku, Finland

Location

Pulssi Medical Center

Turku, Finland

Location

Turku University Hospital, Department of Dermatology and Venereal Diseases

Turku, Finland

Location

Related Publications (8)

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

  PMID: 18385500 BACKGROUND

• 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.

  PMID: 19494826 BACKGROUND

• 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.

  PMID: 6223114 BACKGROUND

• 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.

  PMID: 8435513 BACKGROUND

• 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.

  PMID: 17498413 BACKGROUND

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

  PMID: 2800895 BACKGROUND

• 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.

  PMID: 10494710 BACKGROUND

• 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.

  PMID: 24284985 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Tacrolimus; Ointments

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Sakari Reitamo, Professor

  Helsinki University Central Hospital, Skin and Allergy Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2011
• First Posted: March 22, 2011
• Study Start: March 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 21, 2012

Record last verified: 2012-06

Locations

FI (7)