Clinical trial

Comparison of Metvix PDT With Its Vehicle in the Treatment of Photoaged Skin

Name

RD.03.SPR.29057

Description

Skin photoaging or skin photodamage were terms used to describe the change in the structure, function and appearance of skin caused by prolonged and repeated exposure to sunlight or other ultraviolet light sources. The visible effects of skin photodamage were fine lines, skin sagging, skin roughness, liver spots and also the appearance of red patches made up of thin red vessels (called telangiectasia). More and more people were presenting to doctors with concerns about skin photodamage and the demand for corrective procedures was increasing. Metvix photodynamic therapy (Metvix PDT) is a procedure currently marketed in several countries in Europe (including the United Kingdom \[UK\] and Spain) and in Australia, for the treatment of benign forms of skin cancer (example, actinic keratosis). The aim of the study was to assess whether Metvix PDT would be effective in correcting the effects related to photodamage and whether it would be well tolerated.

Trial arms

Trial start

2007-04-18

Estimated PCD

2008-09-01

Trial end

2008-09-01

Status

Completed

Phase

Early phase I

Treatment

Metvix Cream 160 mg/g

Participants were treated with topical administration of Metvix cream.

Arms:

Metvix Cream 160 mg/g +Metvix Vehicle Cream (1 Hour Group), Metvix Cream 160 mg/g +Metvix Vehicle Cream (2 Hour Group), Metvix Cream 160 mg/g +Metvix Vehicle Cream (3 Hour Group)

Other names:

methyl aminolevulinate

Metvix Vehicle Group

Participants were treated with topical administration of Metvix Vehicle cream.

Arms:

Metvix Cream 160 mg/g +Metvix Vehicle Cream (1 Hour Group), Metvix Cream 160 mg/g +Metvix Vehicle Cream (2 Hour Group), Metvix Cream 160 mg/g +Metvix Vehicle Cream (3 Hour Group)

Size

Primary endpoint

Number of Participants With Severity of Photodamage

At Week 20

Number of Participants With Severity of Mottled Hyper-Pigmentation

At Week 20

Number of Participants With Severity of Fine Lines

At Week 20

Number of Participants With Severity of Telangiectasia

At Week 20

Number of Participants With Severity of Skin Roughness

At Week 20

Number of Participants With Severity of Skin Laxity

At Week 20

Number of Participants With Tolerability Assessment of Erythema

At Week 20

Number of Participants With Tolerability Assessment of Edema

At Week 20

Number of Participants With Tolerability Assessment of Oozing/Crusting

At Week 20

Participant's Skin Discomfort Score Using Visual Analogue Scale (VAS)

At Week 4

Participant's Skin Discomfort Score Using Visual Analogue Scale (VAS)

At Week 8

Number of Participants With Tolerability Assessment of Scaling

At Week 20

Number of Participants With Adverse Events (AEs)

Up to Week 20

Eligibility criteria

Inclusion Criteria: * Male or female participants older than 30 years of age. * Participants with a photodamage grade of at least 4 on the Griffiths photonumeric scale (symmetrical photodamage on the two target areas) * Participants with mottled hyper-pigmentation on the face * Participants willing and capable of cooperating to the extent and degree required by the protocol * Participants must read the Patient Information Sheet and read and sign the Informed Consent form prior to any study related procedures. Exclusion Criteria: * Participants who were at risk in terms of precautions, warnings, and contra-indication in the package insert for Metvix * Participants with suspected porphyria * Participants with specific wash-out period for interfering treatments * Participants requiring concurrent treatment that would interfere with study objectives and/or evaluations

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 32, 'type': 'ACTUAL'}}

Updated at

2024-05-31

1 organization

2 products

1 indication

Organization

Product

Indication

Product