Assessment of the Phototoxic Potential of LEO 29102 Cream

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00958516
• Other study ID #: LEO 29102-C02
• Secondary ID: EudraCT Number 2
• Status: Completed
• Phase: Phase 1
• First received: August 12, 2009
• Last updated: October 24, 2013
• Start date: September 2009
• Est. completion date: October 2009

Study information

• Verified date: October 2013
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• LEO 29102 cream
LEO 29102 cream in different doses and the cream vehicle

Locations

Country	Name	City	State
France	LEO Pharma site	St Quentin en Yvelines Cedex

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phototoxic reaction according to the investigator's assessment		5 days	Yes
Secondary	Clinical scoring and other skin reactions		5 days	Yes