Assessment of the Phototoxic Potential of LEO 29102 Cream

NCT00958516 | Completed Phase 1

• 2 other identifiers: LEO 29102-C02EudraCT Number 2009-011177-32
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to evaluate the phototoxic potential of a single application on healthy skin of LEO 29102 cream in different doses.

Conditions

Atopic Dermatitis

Keywords

volunteers

Outcome Measures

Primary Outcomes (1)

• Phototoxic reaction according to the investigator's assessment

  5 days

Secondary Outcomes (1)

• Clinical scoring and other skin reactions

  5 days

Study Arms (1)

LEO 29102 cream

EXPERIMENTAL

Drug: LEO 29102 cream

Interventions

LEO 29102 cream DRUG

LEO 29102 cream in different doses and the cream vehicle

LEO 29102 cream

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects having understood and signed an informed consent form
• Male adults between the age of 18 and 65 years (both inclusive)
• Healthy subjects without signs of skin irritation on test areas (erythema, dryness, roughness or scaling)
• Subjects willing and able to follow all the study procedures and complete the whole study
• Subjects affiliated to a social security system

You may not qualify if:

• Females
• Males who are not willing to use a local contraception for the entire duration of the study, and refrain from fathering a child within 3 months following the study drug
• Systemic treatments which may interfere with the inflammatory reaction (e.g., corticosteroids and other anti-inflammatory drugs) within 2 weeks prior to randomisation
• Systemic or topical treatments suspected of causing photobiological reactions (e.g., tetracycline, thiazides, fluoroquinolones) within 4 weeks prior to randomisation
• Dark pigmentation of the skin or skin type that may, in any way, confound interpretation of the study results (skin types V and VI on the Fitzpatrick scale)
• Scars, moles, sunburn or other blemishes in the test area which may interfere with grading
• Any systemic or cutaneous disease on the test area that may confound interpretation of the study results (e.g., atopic dermatitis, eczema, psoriasis)
• Relevant history of or concurrent photo-induced or photo-aggravated disease (abnormal response to sunlight
• Subjects with a history of serious allergy, allergic skin rash or known sensitivity to any component of the investigational products
• Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the last four (4) weeks before randomisation
• Participation in any other current interventional clinical trial based on interview of the subject
• Previously randomised in this trial
• Subjects impossible to contact in case of emergency
• Subjects known or, in the opinion of the investigator, are unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state)
• Subjects under guardianship, hospitalised in a public or private institution for a reason other than research or subject deprived of freedom

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

LEO Pharma investigational site

Saint-Quentin-en-Yvelines, 78054, France

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

• Director International Clinical Development, MD

  LEO Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2009
• First Posted: August 13, 2009
• Study Start: September 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: February 24, 2025

Record last verified: 2013-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)