Skin AgingPhase 3NCT00629317
Trial of Methyl Aminolevulinate Plus Aktilite in Facial Photodamage
A Phase 3 study testing Moisturizer and Methyl Aminolevulinate in people with Skin Aging, run by Universidad de Antioquia at 1 site in Colombia.
Trial summary
The aim of the study is to determine the efficacy of MAL + Aktilite versus placebo + Aktilite in facial photodamage in a randomized double blind trial. Read more about this study
- Who is it for?
- Ages 35 to 75 years, women only
- Conditions the study is for
- Skin Aging
- What is being tested?
- Moisturizer and Methyl Aminolevulinate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteColombia
- Study dates
- Feb 2008to Mar 2009
- Phase
- Phase 3
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female subjects older than 35 years of age and less than 75 years of age
- Subjects with a photodamage grade of 2 or 3 according to a modified Dover´s Global photodamage scale
- Subjects willing to participate according to protocol requirements.
- Patients with signed Informed Consent
- Patients with no exclusion criteria
Who cannot join
- Pregnant or nursing females.
- Subjects with suspected porphyria, Systemic or cutaneous erythematosus lupus, or any other photosensitizing disorder or drug induced photosensitization.
- Any active infectious skin disorder ( Herpes simplex, molluscum contagiosum, facial warts )
- Subjects with less than 6 months of previous rejuvenation interfering treatments
- Subjects requiring concurrent treatment that would interfere with study objectives and/or assessments.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
IPS Universitaria - Universidad de Antioquia
Medellín, Antioquia, 01
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial of Methyl Aminolevulinate + Aktilite in Patients With Facial Photodamage
The aim of the study is to determine the efficacy of MAL + Aktilite versus placebo + Aktilite in facial photodamage in a randomized double blind trial.
Read the detailed description
It has been demonstrated that photodamage leads to wrinkles, mottled pigmentation, lentigines, telangiectasias, and textural changes, but more importantly, it can also lead to pre-cancerous conditions with the development of actinic keratosis (AK). The majority of photorejuvenation or photodamaged published studies have used 5-Amino-Levulinic acid (5-ALA) as a photosensitizer, and either a blue light or an Intense Pulsed Light source with a 70%-95% global facial skin improvement. The molecular mechanism of such improvement is unknown, but activation of a non-specific immune response in addition to increased fibrosis and new collagen formation, have both been suggested.
Methyl Aminolevulinate ( MAL) is another marketed photosensitizer mainly utilized in Europe. Lipophilicity, higher penetration depth and tumor selectivity has been advocated for MAL compared to 5-ALA. However, its effect in photodamaged skin has not been well documented.
The aim of the study is to determine the efficacy of MAL + Aktilite (PDT) in facial photodamage.
Study Type: Interventional
Study Design: Randomized, double-Blind, placebo-controlled trial. Official Title: A randomized, double-Blind, placebo-controlled trial of Methyl Aminolevulinate + Aktilite in patients with facial photodamage.
- Conditions
- Skin Aging
- Being tested
- Moisturizer, Methyl Aminolevulinate
- Keywords
- Skin Aging, Rejuvenation, Photodynamic Therapy, Methyl Aminolevulinate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoisturizerOther
Also called Cetaphil
Cetaphil cream(For 3 hours) + Aktilite ( Photodynamic Therapy for 8 minutes)
Methyl AminolevulinateDrug
Also called Metvix
Methyl Aminolevulinate cream for 3 hours before Photodynamic therapy ( Aktilite)
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: Methyl Aminolevulinate |
| B | Placebo comparator | Not described Receives: Other: Moisturizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy in facial global photodamage
Measured: 8 months
Secondary outcomes (3)
Facial fine lines, mottled pigmentation, tactile roughness, sallowness, erythema, telangiectasia
Measured: 12 months
Histological effect of MAL+PDT in fibrosis and new collagen formation
Measured: 12 months
Safety and tolerance
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionJan 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Collaborators
- Galderma R&D
- Investigators
- Gloria Sanclemente, Dr, Principal investigator, Coordinator Group of Investigative Dermatology-GRIDHector I Garcia, Dr., Study chair, Coordinator GRAEPIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00629317
- Sponsor's protocol ID
- PISUI 2007-031
- Status last verified
- Mar 2009
- First submitted
- 25 Feb 2008
- Last updated
- 16 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial of Methyl Aminolevulinate + Aktilite in Patients With Facial Photodamage
- ClinicalTrials.gov ID
- NCT00629317
- Acronym / sponsor ID
- PISUI 2007-031
- Conditions
- Skin Aging
- Keywords
- Skin Aging, Rejuvenation, Photodynamic Therapy, Methyl Aminolevulinate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Collaborators
- Galderma R&D
- Study start
- Feb 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 6 Mar 2008 (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.
The aim of the study is to determine the efficacy of MAL + Aktilite versus placebo + Aktilite in facial photodamage in a randomized double blind trial.
Detailed description
It has been demonstrated that photodamage leads to wrinkles, mottled pigmentation, lentigines, telangiectasias, and textural changes, but more importantly, it can also lead to pre-cancerous conditions with the development of actinic keratosis (AK). The majority of photorejuvenation or photodamaged published studies have used 5-Amino-Levulinic acid (5-ALA) as a photosensitizer, and either a blue light or an Intense Pulsed Light source with a 70%-95% global facial skin improvement. The molecular mechanism of such improvement is unknown, but activation of a non-specific immune response in addition to increased fibrosis and new collagen formation, have both been suggested.
Methyl Aminolevulinate ( MAL) is another marketed photosensitizer mainly utilized in Europe. Lipophilicity, higher penetration depth and tumor selectivity has been advocated for MAL compared to 5-ALA. However, its effect in photodamaged skin has not been well documented.
The aim of the study is to determine the efficacy of MAL + Aktilite (PDT) in facial photodamage.
Study Type: Interventional
Study Design: Randomized, double-Blind, placebo-controlled trial. Official Title: A randomized, double-Blind, placebo-controlled trial of Methyl Aminolevulinate + Aktilite in patients with facial photodamage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Methyl Aminolevulinate |
| B | Placebo comparator | Other: Moisturizer |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female subjects older than 35 years of age and less than 75 years of age
- Subjects with a photodamage grade of 2 or 3 according to a modified Dover´s Global photodamage scale
- Subjects willing to participate according to protocol requirements.
- Patients with signed Informed Consent
- Patients with no exclusion criteria
Key exclusion criteria (5 listed)
- Pregnant or nursing females.
- Subjects with suspected porphyria, Systemic or cutaneous erythematosus lupus, or any other photosensitizing disorder or drug induced photosensitization.
- Any active infectious skin disorder ( Herpes simplex, molluscum contagiosum, facial warts )
- Subjects with less than 6 months of previous rejuvenation interfering treatments
- Subjects requiring concurrent treatment that would interfere with study objectives and/or assessments.
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 |
|---|---|---|
| MoisturizerAlso: CetaphilCetaphil cream(For 3 hours) + Aktilite ( Photodynamic Therapy for 8 minutes) | Other | B |
| Methyl AminolevulinateAlso: MetvixMethyl Aminolevulinate cream for 3 hours before Photodynamic therapy ( Aktilite) | Drug | A |
Primary outcome
Efficacy in facial global photodamage
Time frame: 8 months
3 secondary outcomes
Facial fine lines, mottled pigmentation, tactile roughness, sallowness, erythema, telangiectasia
Time frame: 12 months
Histological effect of MAL+PDT in fibrosis and new collagen formation
Time frame: 12 months
Safety and tolerance
Time frame: 12 months
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 16 Mar 2009.
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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.
Gloria Sanclemente, Dr principal investigator
Coordinator Group of Investigative Dermatology-GRID
Hector I Garcia, Dr. study chair
Coordinator GRAEPIC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Moisturizer and Methyl Aminolevulinate in people with Skin Aging, run by Universidad de Antioquia 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 5 inclusion and 5 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 16 Mar 2009. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Efficacy in facial global photodamage (time frame: 8 months). 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 16 Mar 2009.