Assessment of the Phototoxic Potential of LEO 29102 Cream

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT00958516
First received: August 12, 2009
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Atopic Dermatitis
Drug: LEO 29102 cream
Phase 1

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

Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • Phototoxic reaction according to the investigator's assessment [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical scoring and other skin reactions [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: September 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LEO 29102 cream Drug: LEO 29102 cream
LEO 29102 cream in different doses and the cream vehicle

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00958516

Locations
France
LEO Pharma site
St Quentin en Yvelines Cedex, France, 78054
Sponsors and Collaborators
LEO Pharma
Investigators
Study Director: Director International Clinical Development, MD LEO Pharma
  More Information

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT00958516     History of Changes
Other Study ID Numbers: LEO 29102-C02, EudraCT Number 2009-011177-32
Study First Received: August 12, 2009
Last Updated: October 24, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by LEO Pharma:
volunteers

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014