Comparison of Mechanical Penetration Enhancers on Metvixia Skin Penetration

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Exploratory, mono-center, randomized, intra-individual, controlled trial involving healthy volunteers to compare the effect on MAL penetration into the skin following various mechanical penetration enhancement techniques.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Galderma R&D
• Treatments: Aminolevulinic Acid; Methyl 5-aminolevulinate

Criteria

Inclusion Criteria:

• Male or female of non childbearing potential, who is at least 18 years of age or older at screening visit.

• The subject has a skin phototype of I to III on Fitzpatrick's scale (Fitzpatrick et al., 1993) at screening visit.

• Subject should have 9 mini zone areas on the back that will be able to receive pre-treatments according to protocol. (checked at Screening visit, and assigned at Baseline visit)

• Female of non childbearing potential (postmenopausal [absence of menstrual bleeding for 1 year prior to screening visit, without any other medical reason], hysterectomy or bilateral oophorectomy).

Exclusion Criteria:

• Subject with porphyria,

• Subject with past history of skin cancer, or current clinical diagnosis of other skin disease (including non-melanoma skin cancer), or tattoos, or cheloid and hypertrophic scars on the test zones, which, in the opinion of the investigator, might interfere with the interpretation of the clinical results,

• Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results, and/or put the subject at significant risk (according to Investigator's judgment) if he/she participates in the clinical trial.

• Known or suspected allergies or sensitivities to any components of any of the study drugs (see Product label).

• The subject has received, applied or taken some specific treatments within specified time frame prior to the baseline visit