CT 327 in the "Atopy Patch Test" Model

NCT01368315 | Withdrawn Phase 1

• 1 other identifier: CT 327 AD 01-09
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

A Randomized, Double-Blind, Phase I, Single-Center Study on the Efficacy and Safety of CT 327 in the Atopy Patch Test model.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Result of the Atopy Patch Test (APT): measurement of the eczematous skin reaction (score) after challenge with the appropriate aeroallergen, using European Task Force on Atopic Dermatitis criteria

  13 days

Secondary Outcomes (2)

• Local and systemic tolerance of CT 327

  7 weeks

• Plasma CT327 levels

  10 days

Study Arms (4)

CT327

EXPERIMENTAL

Cream

Drug: CT327 application

Placebo

PLACEBO COMPARATOR

Cream (Vehicle only)

Drug: Placebo

Active comparator

ACTIVE COMPARATOR

Cream

Drug: Active comparator

No intervention

NO INTERVENTION

Drug: No intervention

Interventions

CT327 application DRUG

Topical administration of 0.5 grams cream administered twice daily for ten days to one out of four test fields marked on the patient's back.

CT327

Placebo DRUG

Topical administration of 0.5 grams cream administered twice daily for ten days to one out of four test fields marked on the patient's back.

Placebo

Active comparator DRUG

Topical administration of an active comparator administered twice daily for ten days to one out of four test fields marked on the patient's back.

Active comparator

No intervention DRUG

No intervention to one out of four test fields marked on the patient's back.

No intervention

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 and \< 66 years of age
• Able to give informed consent
• Diagnosis of atopic dermatitis and a positive atopy patch test to at least one of the following(Dermaphagoides pteronyssinus, cat dander, grass or birch pollen)

You may not qualify if:

• Have concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug
• Have a positive response to petrolatum
• Be immune-compromised
• Have any clinically significant abnormal clinical laboratory test results at Screening
• Have a history of malignancy except basal cell carcinoma of the skin.
• Have an active intercurrent infection
• Have applied any topical medication (including corticosteroid, calcineurin inhibitor, topical H1 and H2 antihistamines, topical antimicrobials, other medicated topical agents) or herbal preparation to the area selected for treatment within 14 days prior to study entry.
• Have received antibiotic treatment within 1 week prior to study entry
• Within 4 weeks prior to study entry, have received systemic treatment for atopic dermatitis (including systemic corticosteroids, nonsteroidals, immunosuppressants, or immunomodulating drugs, or treatment with light).
• Have received any investigational drug or been part of any clinical study within the last three months before study entry.
• Have a history of hypersensitivity or allergic reactions to any ingredient in the CT 327 formulation or to the selected active comparator or to polyethyleneglycol.
• If female, are pregnant or lactating, or intend to become pregnant during the study period
• If female, and of child-bearing potential, not taking adequate contraception to avoid pregnancy during and three months after the study.
• History of drug, alcohol or other substance abuse or other factors limiting the ability to cooperate and to comply with the study protocol

Sponsors & Collaborators

• Creabilis SA: lead

Study Sites (1)

Klinik und Poliklinik für Dermatologie und Allergologie Am Biederstein Technische Universität München

Munich, D-80802, Germany

Location

MeSH Terms

Conditions

Dermatitis, Atopic

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

Study Officials

• Prof. Dr. Med. Johannes Ring

  Klinik und Poliklinik für Dermatologie und Allergologie Am Biederstein, Technische Universität München, Munich, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 6, 2011
• First Posted: June 7, 2011
• Last Updated: June 7, 2011

Record last verified: 2011-06

Locations

DE (1)