Assessment of the Phototoxic Potential of LEO 29102 Cream

NCT ID: NCT00958516

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2009-10-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

LEO 29102 cream

Group Type: EXPERIMENTAL

LEO 29102 cream

Intervention Type: DRUG

LEO 29102 cream in different doses and the cream vehicle

Interventions

LEO 29102 cream

LEO 29102 cream in different doses and the cream vehicle

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Exposure to excessive or chronic UV radiation (i.e., sunbathing, solarium, phototherapy) within 4 weeks prior to inclusion or is planned during the study period
• 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 who are in an exclusion period in the National Biomedical Research Register of the French Ministry of Health
• Subjects under guardianship, hospitalised in a public or private institution for a reason other than research or subject deprived of freedom

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Director International Clinical Development, MD

Role: STUDY_DIRECTOR

LEO Pharma

Locations

LEO Pharma investigational site

Saint-Quentin-en-Yvelines, , France

Countries

France

Other Identifiers

EudraCT Number 2009-011177-32

Identifier Type: -

Identifier Source: secondary_id

LEO 29102-C02

Identifier Type: -

Identifier Source: org_study_id