Photoaged SkinPhase 2NCT00437320
Comparison of Metvix Photodynamic Therapy (PDT) With Its Vehicle in the Treatment of Photoaged Skin
A Phase 2 study testing Metvix Cream 160 mg/g in people with Photoaged Skin, run by Galderma R&D at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Photoaged Skin
- What is being tested?
- Metvix Cream 160 mg/g
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 18 Apr 2007to 1 Sep 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United Kingdom2 sites
Whittington Hospital
London
University of Manchester-Hope Hospital
Manchester
About this study
Official title: Comparison of Metvix PDT With Its Vehicle in the Treatment of Photoaged Skin
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).
Read more
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.
Read the detailed description
Different application times of the study treatment were being investigated.
- Conditions
- Photoaged Skin
- Being tested
- Metvix Cream 160 mg/g, Metvix Vehicle Group
- Keywords
- PDT, Photoaging, Galderma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metvix Cream 160 mg/gDrug
Also called methyl aminolevulinate
Participants were treated with topical administration of Metvix cream.
Metvix Vehicle GroupDrug
Participants were treated with topical administration of Metvix Vehicle cream.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Metvix Cream 160 mg/g; Drug: Metvix Vehicle Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2007 (estimated)
- Study start18 Apr 2007
- Primary completion1 Sep 2008
- Study completion1 Sep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Photoaged SkinStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- CEM Griffiths, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00437320
- Sponsor's protocol ID
- RD.03.SPR.29057
- Other IDs
- 2006-004237-15
- Status last verified
- Dec 2023
- First submitted
- 19 Feb 2007
- Last updated
- 31 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol was submitted to and approved by the local Ethics Committees prior to study initiation, and by the regulatory authorities. The study was followed-up closely by the Sponsor or representatives according to the Declaration of Helsinki (1964) and its Tokyo 9(175), Venice (1983), Hong-Kong (1989), Somerset West (1996), and Edinburgh (2000) amendments, the ICH Good Clinical Practice (GCP) principles, Standard Operating Procedures (SOPs) and local regulatory requirements.
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Metvix PDT With Its Vehicle in the Treatment of Photoaged Skin
- ClinicalTrials.gov ID
- NCT00437320
- Acronym / sponsor ID
- RD.03.SPR.29057
- Conditions
- Photoaged Skin
- Keywords
- PDT, Photoaging, Galderma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2007 (actual)
- Primary completion
- 1 Sep 2008 (actual)
- Study completion
- 1 Sep 2008 (actual)
- First posted
- 21 Feb 2007 (estimated)
- Results
- Posted 31 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Different application times of the study treatment were being investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metvix Cream 160 mg/g +Metvix Vehicle Cream (1 Hour Group) | Experimental | Drug: Metvix Cream 160 mg/g, Drug: Metvix Vehicle GroupParticipants 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. |
| Metvix Cream 160 mg/g +Metvix Vehicle Cream (2 Hour Group) | Experimental | Drug: Metvix Cream 160 mg/g, Drug: Metvix Vehicle GroupParticipants 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. |
| Metvix Cream 160 mg/g +Metvix Vehicle Cream (3 Hour Group) | Experimental | Drug: Metvix Cream 160 mg/g, Drug: Metvix Vehicle GroupParticipants 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metvix Cream 160 mg/gAlso: methyl aminolevulinateParticipants were treated with topical administration of Metvix cream. | Drug | 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 GroupParticipants were treated with topical administration of Metvix Vehicle cream. | Drug | 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) |
Primary outcome
Number of Participants With Severity of Photodamage
Time frame: At Week 20
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.
Number of Participants With Severity of Mottled Hyper-Pigmentation
Time frame: At Week 20
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.
Number of Participants With Severity of Fine Lines
Time frame: At Week 20
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.
Number of Participants With Severity of Telangiectasia
Time frame: At Week 20
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.
Number of Participants With Severity of Skin Roughness
Time frame: At Week 20
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.
Number of Participants With Severity of Skin Laxity
Time frame: At Week 20
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.
Number of Participants With Tolerability Assessment of Erythema
Time frame: At Week 20
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.
Number of Participants With Tolerability Assessment of Edema
Time frame: At Week 20
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.
Number of Participants With Tolerability Assessment of Oozing/Crusting
Time frame: At Week 20
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.
Participant's Skin Discomfort Score Using Visual Analogue Scale (VAS)
Time frame: At Week 4
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.
Participant's Skin Discomfort Score Using Visual Analogue Scale (VAS)
Time frame: At Week 8
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.
Number of Participants With Tolerability Assessment of Scaling
Time frame: At Week 20
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.
Number of Participants With Adverse Events (AEs)
Time frame: Up to Week 20
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The study protocol was submitted to and approved by the local Ethics Committees prior to study initiation, and by the regulatory authorities. The study was followed-up closely by the Sponsor or representatives according to the Declaration of Helsinki (1964) and its Tokyo 9(175), Venice (1983), Hong-Kong (1989), Somerset West (1996), and Edinburgh (2000) amendments, the ICH Good Clinical Practice (GCP) principles, Standard Operating Procedures (SOPs) and local regulatory requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CEM Griffiths principal investigator
Professor
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metvix Cream 160 mg/g in people with Photoaged Skin, run by Galderma R&D at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Severity of Photodamage (time frame: At Week 20). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.