Assessment of the Phototoxic Potential of LEO 29102 Cream

A Phase 1 Study Evaluating the Phototoxic Potential of LEO 29102 Cream (2.5 mg/g, 1.0 mg/g, 0.3 mg/g, 0.1 mg/g, 0.03 mg/g) and the Cream Vehicle, Applied on Intact Skin of Healthy Male Subjects

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: LEO 29102 cream

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • St Quentin en Yvelines Cedex, France, 78054
    • LEO Pharma site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LEO 29102 cream	Drug: LEO 29102 cream; LEO 29102 cream in different doses and the cream vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Phototoxic reaction according to the investigator's assessment	5 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical scoring and other skin reactions	5 days

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Study Director: Director International Clinical Development, MD, LEO Pharma

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: August 12, 2009
• First Submitted That Met QC Criteria: August 12, 2009
• First Posted (Estimate): August 13, 2009

Study Record Updates

• Last Update Posted (Estimate): October 25, 2013
• Last Update Submitted That Met QC Criteria: October 24, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: volunteers
• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis
• Other Study ID Numbers: LEO 29102-C02; EudraCT Number 2009-011177-32