Actinic KeratosisPDTNCT00843323
Photodynamic Therapy (PDT) Effect on Large Surface Photodamaged Skin
A study testing Methylaminolevulinate - photodynamic therapy in people with Actinic Keratosis and Photoaging, run by University of Sao Paulo.
Trial summary
In this study, 26 patients were selected and included for full-face photodynamic therapy sessions. All patients presented signs of photoaging skin and multiple actinic keratosis. Photographs and Biopsies were taken before and after the procedure. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Actinic Keratosis, Photoaging, Solar Elastosis
- What is being tested?
- Methylaminolevulinate - photodynamic therapy
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Jun 2009
- Phase
- Interventional
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with severe photodamage and at least 3 actinic keratosis on the face
Who cannot join
- Pregnancy, laser, chemical peel, imiquimod or 5-Fu treatment in the last year
About this study
Official title: Histological and Immunohistochemical Study of Photodamaged Skin Submitted to MAL-PDT
In this study, 26 patients were selected and included for full-face photodynamic therapy sessions. All patients presented signs of photoaging skin and multiple actinic keratosis. Photographs and Biopsies were taken before and after the procedure. Clinical and histological aspects as well as immunohistochemical aspects regarding neocollagen induction and tumor expression were evaluated.
Read the detailed description
Study design:
Patients and methods:
26 patients (16 females, 8 males) age 35-90 years, mean 59,4 y Skin types I-IV, severely photodamaged facial skin Multiples Aks on the face ( total 268) minimum of 3 per patient Approved by local ethical committee and informed consent given
Treatment procedure:
Prior curettage Full-face MAL application ( Metvix ®, Galderma France) 1,5 tube per treatment Incubation time 3 hs - in the first treatment session; and 1,5 h - in the 2 nd and 3 rd sessions Illumination LED (Aktilite® Photocure, Norway) 635 nm 37 J/cm2 3 treatments performed, one month apart Pain monitoring: forced air cooling device
Evaluation:
Clinical - 5 point scale based on Dover's and Zane's studies Dover JS et al. Topical ALA combined with IPL in photoaging. Arch Dermatol 2005; 141: 1247-52 Zane et al. Clinical and echographical analysis of MAL- PDT in photodamaged skin. Laser Surg Med 2007; 39: 203-9
Histological - Hematoxilin- Eosin staining
Immunohistochemical study- HP 53, Metalloproteinases, Procollagen I,
- Conditions
- Actinic Keratosis, Photoaging, Solar Elastosis
- Being tested
- Methylaminolevulinate - photodynamic therapy
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylaminolevulinate - photodynamic therapyOther
Methylaminolevulinate cream 16% applied for 3 hours under occlusion on the face and then illuminated with red LED device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study startDec 2008
- Primary completionMar 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- University of Regensburg
- Responsible party
- Principal investigator, Luis Antonio Torezan, University of Sao Paulo
- Investigators
- Luis A Torezan, MD, Principal investigator, Hospital das Clinicas - Faculdade de Medicina USP - Sao Paulo- Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00843323
- Sponsor's protocol ID
- 0614/08
- Acronym
- PDT
- Status last verified
- May 2023
- First submitted
- 12 Feb 2009
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological and Immunohistochemical Study of Photodamaged Skin Submitted to MAL-PDT
- ClinicalTrials.gov ID
- NCT00843323
- Acronym / sponsor ID
- PDT / 0614/08
- Conditions
- Actinic Keratosis, Photoaging, Solar Elastosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- University of Regensburg
- Study start
- Dec 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 13 Feb 2009 (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.
In this study, 26 patients were selected and included for full-face photodynamic therapy sessions. All patients presented signs of photoaging skin and multiple actinic keratosis. Photographs and Biopsies were taken before and after the procedure. Clinical and histological aspects as well as immunohistochemical aspects regarding neocollagen induction and tumor expression were evaluated.
Detailed description
Study design:
Patients and methods:
26 patients (16 females, 8 males) age 35-90 years, mean 59,4 y Skin types I-IV, severely photodamaged facial skin Multiples Aks on the face ( total 268) minimum of 3 per patient Approved by local ethical committee and informed consent given
Treatment procedure:
Prior curettage Full-face MAL application ( Metvix ®, Galderma France) 1,5 tube per treatment Incubation time 3 hs - in the first treatment session; and 1,5 h - in the 2 nd and 3 rd sessions Illumination LED (Aktilite® Photocure, Norway) 635 nm 37 J/cm2 3 treatments performed, one month apart Pain monitoring: forced air cooling device
Evaluation:
Clinical - 5 point scale based on Dover's and Zane's studies Dover JS et al. Topical ALA combined with IPL in photoaging. Arch Dermatol 2005; 141: 1247-52 Zane et al. Clinical and echographical analysis of MAL- PDT in photodamaged skin. Laser Surg Med 2007; 39: 203-9
Histological - Hematoxilin- Eosin staining
Immunohistochemical study- HP 53, Metalloproteinases, Procollagen I,
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with severe photodamage and at least 3 actinic keratosis on the face
Key exclusion criteria (1 listed)
- Pregnancy, laser, chemical peel, imiquimod or 5-Fu treatment in the last year
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 |
|---|---|---|
| Methylaminolevulinate - photodynamic therapyMethylaminolevulinate cream 16% applied for 3 hours under occlusion on the face and then illuminated with red LED device | Other | – |
Primary outcome
Not reported in the source record.
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 10 May 2023.
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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.
Luis A Torezan, MD principal investigator
Hospital das Clinicas - Faculdade de Medicina USP - Sao Paulo- Brazil
Questions about this trial
What is this clinical trial studying?
A study testing Methylaminolevulinate - photodynamic therapy in people with Actinic Keratosis and Photoaging, run by University of Sao Paulo.
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 1 inclusion and 1 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 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
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.
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 10 May 2023.