Phase 2 N=32 Randomized Triple-blind Treatment

Comparison of Metvix Photodynamic Therapy (PDT) With Its Vehicle in the Treatment of Photoaged Skin

Photoaged Skin

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View on ClinicalTrials.gov: NCT00437320 ↗

Enrolled (actual)

Serious AEs

6.3%

Results posted

May 2024

Primary outcome: Primary: Number of Participants With Severity of Photodamage — 0; 0; 1; 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Metvix Cream 160 mg/g (Drug); Metvix Vehicle Group (Drug)
Age: Adult, Older Adult · 30+ yrs
Sex: All
Sponsor: Galderma R&D
Primary completion: Sep 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Severity of Photodamage	0; 0; 1; 0; 0; 0	—
PRIMARY Number of Participants With Severity of Mottled Hyper-Pigmentation	1; 0; 0; 0; 1; 0	—
PRIMARY Number of Participants With Severity of Fine Lines	3; 7; 2; 3; 4; 4	—
PRIMARY Number of Participants With Severity of Telangiectasia	0; 0; 2; 1; 1; 0	—
PRIMARY Number of Participants With Severity of Skin Roughness	1; 1; 3; 2; 4; 4	—
PRIMARY Number of Participants With Severity of Skin Laxity	0; 0; 1; 0; 0; 0	—
PRIMARY Number of Participants With Tolerability Assessment of Erythema	5; 8; 0; 5; 0; 9	—
PRIMARY Number of Participants With Tolerability Assessment of Edema	5; 8; 5; 7; 4; 10	—
PRIMARY Number of Participants With Tolerability Assessment of Oozing/Crusting	8; 9; 7; 8; 6; 10	—
PRIMARY Participant's Skin Discomfort Score Using Visual Analogue Scale (VAS)	3.0; 0.0; 4.9; 0.0; 6.4; 0.2	—
PRIMARY Participant's Skin Discomfort Score Using Visual Analogue Scale (VAS)	3.0; 0.0; 4.9; 0.0; 6.4; 0.2	—
PRIMARY Number of Participants With Tolerability Assessment of Scaling	8; 8; 6; 8; 7; 10	—
PRIMARY Number of Participants With Adverse Events (AEs)	1; 3; 8	—

Summary

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00437320). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.