Facial PhotodamagePhase 2NCT02139618
Efficacy of Methyl Aminolevulinate + Daylight in Patients With Facial Photodamage
A Phase 2 study testing Methyl Aminolevulinate (MAL) in people with Facial Photodamage, run by Fundación Dermabase at 1 site in Colombia.
Trial summary
Treatment of actinic damage has included multiple procedures but to date there is limited scientific evidence to support the preferential use of one of these therapies according to their efficacy, safety and pain tolerance by patients. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Facial Photodamage
- What is being tested?
- Methyl Aminolevulinate (MAL)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteColombia
- Study dates
- Apr 2014to Oct 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with symmetric facial photodamage grade 2 or 3 (Dover´s scale)
- Patients willing to participate
- Signed informed consent
Who cannot join
- Pregnant or nursing females
- Subjects with any photosensitizing disorder
- Any active infectious skin disorder
- History of herpes simplex in the face
- Subjects with less than 6 months of any previous rejuvenation interfering treatments
- History of systemic isotretinoin in the last year
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- Subjects requiring concurrent treatment that would interfere with study objectives and/or assessments
- History of hypersensitivity reactions
- Activities with high sun exposure during 48 hours after treatment
- Clinical suspicion of any systemic or local malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind Randomized-controlled Trial to Assess the Efficacy of Methyl Aminolevulinate + Daylight vs Placebo + Daylight in Patients With Facial Photodamage
Treatment of actinic damage has included multiple procedures but to date there is limited scientific evidence to support the preferential use of one of these therapies according to their efficacy, safety and pain tolerance by patients. This study aims to assess the efficacy of methyl aminolevulinate + daylight vs placebo + daylight to treat facial photodamage
- Conditions
- Facial Photodamage
- Being tested
- Methyl Aminolevulinate (MAL), Placebo
- Keywords
- Randomized-controlled-trial, Methyl-Aminolevulinate, Daylight, Photodynamic-therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methyl Aminolevulinate (MAL)Drug
Also called Metvix®
PlaceboDrug
Also called Vehicle
| Study group | Role | What they receive |
|---|---|---|
| Methyl Aminolevulinate (MAL) | Experimental | 1 gram of Topical Methyl Aminolevulinate (MAL) applied to the whole face 30 minutes before sun exposure for 2 hours (3 sessions , 2 to 4 weeks apart) Receives: Drug: Methyl Aminolevulinate (MAL) |
| Placebo | Placebo comparator | 1 gram of placebo cream applied to the whole face 30 minutes before sun exposure for 2 hours (3 sessions , 2 to 4 weeks apart) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global photodamage improvement
The primary outcome is global photodamage improvement 1 month after the third daylight PDT session, according to Dover´s photodamage scale.
Measured: 1 month after third session
Secondary outcomes (6)
Pain measurement
Pain evaluation with the visual analogue scale after 2 hours of sun exposure in each of the sessions performed (Sessions 1, 2 and 3).
Measured: After 2 hours of sun exposure in each session
Specific Photodamage score
Specific photodamage severity score for fine lines, coarse lines, tactile roughness, mottled pigmentation, sallowness, and erythema one month after the third daylight PDT session, according to Dover´s photodamage scale.
Measured: 1 month after the third session
Sun irradiance and illuminance quantification
Sun irradiation and illuminance quantification during exposure
Measured: During the 2 hours of each session
Adverse events
Any adverse event
Measured: From recruitment until 1 month after the third session
Therapy tolerance
Therapy tolerance will be recorded with a scale that includes a 4-grade severity score for oozing, erythema, oedema, desquamation, pigmentation, and vesiculation.
Measured: 1 week after sessions 1,2 and 3
Quality of life assessment (Skindex-29 Instrument)
Quality of life assessment (Skindex-29 Instrument)
Measured: Basal and 1 month after the third session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startApr 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial PhotodamageStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Dermabase
- Sponsor type
- University, hospital or other
- Collaborators
- Grupo de Investigacion Dermatologica (GRID), IPS Universitaria-Universidad de Antioquia
- Responsible party
- Sponsor
- Investigators
- Gloria Sanclemente, Dr, Principal investigator, Universidad de Antioquia. Medellin, Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139618
- Sponsor's protocol ID
- 2013-01INT
- Status last verified
- Mar 2015
- First submitted
- 29 Apr 2014
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Randomized-controlled Trial to Assess the Efficacy of Methyl Aminolevulinate + Daylight vs Placebo + Daylight in Patients With Facial Photodamage
- ClinicalTrials.gov ID
- NCT02139618
- Acronym / sponsor ID
- 2013-01INT
- Conditions
- Facial Photodamage
- Keywords
- Randomized-controlled-trial, Methyl-Aminolevulinate, Daylight, Photodynamic-therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fundación DermabaseUniversity, hospital or other
- Collaborators
- Grupo de Investigacion Dermatologica (GRID), IPS Universitaria-Universidad de Antioquia
- Study start
- Apr 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 15 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Treatment of actinic damage has included multiple procedures but to date there is limited scientific evidence to support the preferential use of one of these therapies according to their efficacy, safety and pain tolerance by patients. This study aims to assess the efficacy of methyl aminolevulinate + daylight vs placebo + daylight to treat facial photodamage
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methyl Aminolevulinate (MAL) | Experimental | Drug: Methyl Aminolevulinate (MAL)1 gram of Topical Methyl Aminolevulinate (MAL) applied to the whole face 30 minutes before sun exposure for 2 hours (3 sessions , 2 to 4 weeks apart) |
| Placebo | Placebo comparator | Drug: Placebo1 gram of placebo cream applied to the whole face 30 minutes before sun exposure for 2 hours (3 sessions , 2 to 4 weeks apart) |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults with symmetric facial photodamage grade 2 or 3 (Dover´s scale)
- Patients willing to participate
- Signed informed consent
Key exclusion criteria (10 listed)
- Pregnant or nursing females
- Subjects with any photosensitizing disorder
- Any active infectious skin disorder
- History of herpes simplex in the face
- Subjects with less than 6 months of any previous rejuvenation interfering treatments
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 |
|---|---|---|
| Methyl Aminolevulinate (MAL)Also: Metvix® | Drug | Methyl Aminolevulinate (MAL) |
| PlaceboAlso: Vehicle | Drug | Placebo |
Primary outcome
Global photodamage improvement
Time frame: 1 month after third session
The primary outcome is global photodamage improvement 1 month after the third daylight PDT session, according to Dover´s photodamage scale.
6 secondary outcomes
Pain measurement
Time frame: After 2 hours of sun exposure in each session
Specific Photodamage score
Time frame: 1 month after the third session
Sun irradiance and illuminance quantification
Time frame: During the 2 hours of each session
Adverse events
Time frame: From recruitment until 1 month after the third session
Therapy tolerance
Time frame: 1 week after sessions 1,2 and 3
Quality of life assessment (Skindex-29 Instrument)
Time frame: Basal and 1 month after the third session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
Related trials for Facial Photodamage
Not yet recruiting
Evaluation of the Efficacy and Tolerability of the LED Mask With or Without the Serum Formula on the Signs of Facial Photodamage .
Photodamage of the Face, Anti Aging
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.
Gloria Sanclemente, Dr principal investigator
Universidad de Antioquia. Medellin, Colombia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methyl Aminolevulinate (MAL) in people with Facial Photodamage, run by Fundación Dermabase at 1 site in Colombia.
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 3 inclusion and 10 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 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Global photodamage improvement (time frame: 1 month after third session). 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 6 Mar 2015.