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

NCT00437320 | Completed Phase 2 Results

• 2 other identifiers: RD.03.SPR.290572006-004237-15
• Study Type: interventional
• Target: 32
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

Photoaged Skin

Keywords

PDT; Photoaging; Galderma

Outcome Measures

Primary Outcomes (13)

• Number of Participants With Severity of Photodamage

  Severity of cutaneous photodamage in participants were assessed using Griffiths photo numeric scale. The severity scores of photodamage on the scale ranged from 0 (minimum) to 8 (maximum), that is, no damage (0), mild damage (1-3), moderate damage (4-6), and severe damage (7-8) where the highest score indicated worst outcome.

  At Week 20

• Number of Participants With Severity of Mottled Hyper-Pigmentation

  The evaluation of the severity of facial mottled hyperpigmentation were done using five-point scale. The score on the five-point scale ranged from 0 (minimum) to 4 (maximum), that is, 0 = none (no areas of mottled, irregular pigmentation), 1 = minimal (few, small lightly pigmented, discrete macules), 2 = mild (multiple, small lightly pigmented macules), 3 = moderate (widespread areas of mottled, moderately dark macules), 4 = severe (Widespread, multiple areas of dark macules/hyperpigmentation with uneven skin tone). The higher score indicated the worse outcome.

  At Week 20

• Number of Participants With Severity of Fine Lines

  The evaluation of the severity of facial fine lines were done using the five-point scale ranging from 0 to 4, that is, 0 = none- (lines disappear with stretching), 1 = minimal (few lines which do not completely disappear with stretching), 2 = mild (few lines which only diminish with stretching), 3 = moderate (widespread areas of lines which change minimally with stretching), 4 = severe- (widespread areas of lines which do not change at all with stretching), where the higher score indicated the worse outcome.

  At Week 20

• Number of Participants With Severity of Telangiectasia

  The severity of telangiectasia by using the scale ranging from 0 (minimum) to 3 (maximum), that is, 0 = absent (no telangiectasia), 1 = mild (slight telangiectasia characterized by appearance of a few fine, small red vessels \[0.2 millimeters \[mm\] or less in diameter); telangiectasia covers less than 10 percent (%) of the target area, 2 = moderate (pronounced telangiectasia characterized by appearance of several fine vessels and/or few large vessels \[0.2 mm or greater in diameter\]; telangiectasia covers between 10 to 30% of the target area), 3 = severe (severe telangiectasia characterized by the appearance of many fine vessels and/or large vessels; telangiectasia covers greater than 30% of the target area), where the higher score indicated the worse outcome.

  At Week 20

• Number of Participants With Severity of Skin Roughness

  The evaluation of the severity of skin roughness were done by using the five-point scale ranging from 0 to 4,that is, 0 = none ( very smooth, no patches of roughness), 1 = minimal (smooth with only a few patches of roughness), 2 = mild (mostly smooth with scattered patches of roughness), 3 = moderate (slightly rough with diffuse patches of roughness), 4 = severe (rough with diffuse areas of roughness, some scales may be visible), where the higher score indicated the worse outcome.

  At Week 20

• Number of Participants With Severity of Skin Laxity

  The evaluation of the severity of skin laxity were done by using the scale ranging from 0 to 3 that is, 0 = none (no skin laxity), 1 = mild (mild skin sagging), 2 = moderate (moderate skin sagging), 3 = severe (severe skin sagging), where the higher score indicated the worse outcome.

  At Week 20

• Number of Participants With Tolerability Assessment of Erythema

  Erythema was defined as an abnormal redness of the skin and was measured on the scale score ranging from 0 (minimum) to 3 (maximum) that is, 0 = none (no erythema),1 = mild (slight pinkness present), 2 = moderate (definite redness, easily recognized), and 3 = severe (intense redness), where the higher score indicated the worse outcome.

  At Week 20

• Number of Participants With Tolerability Assessment of Edema

  Abnormal tenseness of the skin was measured on a scale ranging from 0 to 3. 0 (none) no edema, 1 (mild) slight tenseness of skin without firmness, 2 (moderate) moderate tenseness of the skin with slight firmness, 3 (severe) severe tenseness of the skin with resistance to distortion. The higher score means the worse outcome.

  At Week 20

• Number of Participants With Tolerability Assessment of Oozing/Crusting

  Oozing/crusting was a continuing process of exudation of fluid from the lesions/formation of scab-like material on the surface of lesions resulting from dried serum. Oozing/crusting was assessed on a scale ranging from 0-3. 0 (none) no oozing/crusting, 1 (mild) faint sign of oozing and/or weeping; slight crusting on a few of the lesions, 2 (moderate) definite oozing, but not extensive (a few lesions/areas); definite crusting on several of the lesions, 3 (severe) marked oozing/weeping; heavy crusting on the majority of the lesions. The higher score indicated the worse outcome.

  At Week 20

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

  Participant skin discomfort was evaluated on a scale of 0 to 10. 0 ("no skin discomfort") to 10 ("worst possible skin discomfort") evaluation of skin discomfort (including pain and itching) on each half-face was analyzed using a VAS. The higher score indicated the worse outcome.

  At Week 4

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

  Participant skin discomfort was evaluated on a scale of 0 to 10. 0 ("no skin discomfort") to 10 ("worst possible skin discomfort") evaluation of skin discomfort (including pain and itching) on each half-face was analyzed using a VAS. The higher score indicated the worse outcome.

  At Week 8

• Number of Participants With Tolerability Assessment of Scaling

  Abnormal shedding of the stratum corneum is measured on a scale 0 to 3. 0 (none) no scaling, 1 (mild) barely perceptible shedding, noticeable only on light scratching or rubbing, 2 (moderate) obvious but not profuse shedding, 3 (severe) heavy scale production. The higher score indicated the worse outcome.

  At Week 20

• Number of Participants With Adverse Events (AEs)

  AE was defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the study drug. Abnormalities presented at Baseline were considered AEs if they reoccurred after resolution or worsen during the AE collection period. Number of participants with AEs were reported.

  Up to Week 20

Study Arms (3)

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

EXPERIMENTAL

Participants were topically treated with 160 milligrams per gram (mg/g) Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light \[using a large-field light emitting diode (LED) light source: Aktilite 128 lamp\] during 7 to 10 minutes to deliver a total dose of 37 Joules per centimeter square J/cm\^2. The total study duration was 20 weeks.

Drug: Metvix Cream 160 mg/g; Drug: Metvix Vehicle Group

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

EXPERIMENTAL

Participants were topically treated with 160 mg/g Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\^2. The total study duration was 20 weeks.

Drug: Metvix Cream 160 mg/g; Drug: Metvix Vehicle Group

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

EXPERIMENTAL

Participants were topically treated with 160 mg/g Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\^2. The total study duration was 20 weeks.

Drug: Metvix Cream 160 mg/g; Drug: Metvix Vehicle Group

Interventions

Metvix Cream 160 mg/g DRUG

Participants were treated with topical administration of Metvix cream.

Also known as: methyl aminolevulinate

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)

Metvix Vehicle Group DRUG

Participants were treated with topical administration of Metvix Vehicle cream.

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)

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (3)

Policlinico Ruber

Madrid, Spain

Location

Whittington Hospital

London, United Kingdom

Location

University of Manchester-Hope Hospital

Manchester, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Interventions

methyl 5-aminolevulinate

Results Point of Contact

• Title: Clinical Operations
• Organization: Galderma

Clinical.Studies@galderma.com

817 961 5000

Study Officials

• CEM Griffiths

  Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2007
• First Posted: February 21, 2007
• Study Start: April 18, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: May 31, 2024
• Results First Posted: May 31, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share

Locations

ES (1); GB (2)