PhotoagingPhase 3NCT01405144
5fluorouracil for Advanced Photoaging
A Phase 3 study testing 5-fluoruracil in people with Photoaging and Actinic Keratosis, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
It is well known the efficacy of 5% 5-fluoruracil for multiple and superficial actinic keratosis (AKs)treatment. Recently its additional benefit for advanced and severe photoaging while treating Aks was reported. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Photoaging, Actinic Keratosis
- What is being tested?
- 5-fluoruracil
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2010to Mar 2012
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Men and women, aged from 50 to 75 anos;
- Phototype I a III (Fitzpatrick Classification);
- Advanced photoaging on forearms, with multiple superficial actinic keratosis;
- Agreement with no sun exposure during the study and
- Agreement with study conditions,capacity to understand and follow the orientations and form consent signature.
Who cannot join
- Topical treatment with:
- tretinoin in the last 6 months ;
- other retinoids, alpha-hydroxyacids, poli-hydroxyacids, beta-hydroxyacids and ascorbic acid in the last 3 months;
- Treatment by chemical peeling, microdermabrasion and non-ablative laser in the last 3 months;
- Treatment with systemic retinoid in the last 6 months ;
- Chemotherapy in the last 3 months;
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- Hypersensibility to parabens;
- Infectious or inflammatory dermatosis on forearms;
- Clinical evidence of immunosuppression and
- Presence of photodermatosis
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Edileia Bagatin
São Paulo, São Paulo, 04075-000
Carolina Zerbini, MD, 55-15-97280079, carolzerbini@hotmail.com
Carolina Zerbini, MD
About this study
Official title: Phase III Comparative Study About the Use of 5% 5-fluorouracil Cream Versus Its Utilization as Agent for Sequential Superficial Peeling in the Treatment of Advanced Photoaging
It is well known the efficacy of 5% 5-fluoruracil for multiple and superficial actinic keratosis (AKs)treatment. Recently its additional benefit for advanced and severe photoaging while treating Aks was reported.
The aim of this study is to compare the efficacy and safety of the two modalities of 5% 5-FU use for forearms photoaging.
Read the detailed description
The use of 5% 5-fluorouracil (5-FU) cream, twice a day, during 3 weeks represents a classic treatment for multiple and superficial AKs. The main adverse event is the severe skin irritation leading to interruption of the treatment in some cases. In the last decade a superficial pulse-peeling using it as agent in sequential applications was described. This modality of treatment has been demonstrated efficacy and better tolerability.
The improvement of the overall aspect of photodamaged skin is observed while treating multiple AKs.
There are no comparative study between the two types of 5% 5-FU use. So that is the purpose of our clinical trial.
- Conditions
- Photoaging, Actinic Keratosis
- Being tested
- 5-fluoruracil
- Keywords
- Photoaging, Actinic keratosis, 5-fluoruracil, Carcinogenesis
- Medical subject headings
- Keratosis, Actinic, Carcinogenesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-fluoruracilDrug
Also called Topical treatment
5% 5-fluoruracil cream, twice a day, during 3 weeks
5-fluoruracilProcedure or surgery
Also called Cosmetic procedure
The same 30 patients will be submitted to 4 weekly application of superficial peeling using 5% 5-fluoruracil in propyleneglycol as vehicle. The applications will be performed by physician (one of the co-investigators)
| Study group | Role | What they receive |
|---|---|---|
| 5% 5-fluoruracil cream | Active comparator | 30 patients will use 5% 5-fluoruracil cream, twice a day, during 3 weeks, in one randomized forearm Receives: Drug: 5-fluoruracil |
| 5% 5-fluoruracil peeling | Active comparator | The same 30 patients will be submitted to 4 applications of 5% 5-fluoruracil superficial peeling in the other forearm Receives: Procedure: 5-fluoruracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Photographic Evaluation
Photographic blinded evaluation by two independent observers, comparing modifications of forearms skin overall aspect before and after 60 and 180 days of the treatments. The following 5 point scale will be used: -2=much worse; -1=worse; 0=inlatered; 1=better, 2= much better
Measured: 0, 60, 180 days
Change in Microscopic Evaluation
Skin biopsies will be performed and coloration by hematoxilin-eosin, Verhoeff, Tricromio Masson , Picrosirius and biomarkers (p53, bcl2, collagen 1)will be used. The modifications on corneal layer and epidermal thickness, dermal elastotic material and collagen deposition and biomarkers expression will be evaluated by digital quantitative analysis, comparing the findings before (day 0) and after (day 180)treatments.
Measured: 0, 180 days
Secondary outcomes (5)
Inflammatory Skin Reaction
Comparison between treatments on inflammatory skin reaction will be performed by expression of interleucin-1, using immunohistochemistry
Measured: 30 day
Occurence and Evaluation of Adverse Events
Predictable and unpredictable side effects and their intensity related by patient and/or observed by investigator will be analized and compared between the treatments
Measured: 30, 60, 180 days
Change in Patient Opinion
Patient opinion concerning modification on forearms skin overall aspect, using a 5 point scale: -2=much worse; -1=worse; 0=inaltered; 1=better, 2= much better, comparing day 0 to 60, 60 to 180 and 0 to 180.
Measured: 0, 30, 60, 180 days
Change in Investigator Clinical Evaluation
Investigator efficacy evaluation through actinic keratosis counting, on days 0, 30, 60 and 180 as weel as modification on forearms skin overall aspect. That will be performed by comparision of skin examination on days 60 and 180 to photography captured on days 0 and 60, i.e, 0 to 60, 60 to 180 and 0 to 180, using a 5 point scale: -2=much worse; -1=worse; 0=inaltered; 1=better, 2= much better
Measured: 0, 30, 60, 180 days
Change in Forearm Photoaging Classification
A classification will be created and validated by investigators and five independent observers previously to classify forearm photoaging. After validation it will be applied to study subjects on days 0, 60 and 180 to evaluate modification on the forearm photoaging grade for each tretament.
Measured: 0, 60, 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study startAug 2010
- Primary completionSep 2011 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhotoagingStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Ediléia Bagatin, PhD, Study chair, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01405144
- Sponsor's protocol ID
- Carol2011
- Status last verified
- May 2011
- First submitted
- 5 Jul 2011
- Last updated
- 29 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Comparative Study About the Use of 5% 5-fluorouracil Cream Versus Its Utilization as Agent for Sequential Superficial Peeling in the Treatment of Advanced Photoaging
- ClinicalTrials.gov ID
- NCT01405144
- Acronym / sponsor ID
- Carol2011
- Conditions
- Photoaging, Actinic Keratosis
- Keywords
- Photoaging, Actinic keratosis, 5-fluoruracil, Carcinogenesis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 29 Jul 2011 (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.
It is well known the efficacy of 5% 5-fluoruracil for multiple and superficial actinic keratosis (AKs)treatment. Recently its additional benefit for advanced and severe photoaging while treating Aks was reported.
The aim of this study is to compare the efficacy and safety of the two modalities of 5% 5-FU use for forearms photoaging.
Detailed description
The use of 5% 5-fluorouracil (5-FU) cream, twice a day, during 3 weeks represents a classic treatment for multiple and superficial AKs. The main adverse event is the severe skin irritation leading to interruption of the treatment in some cases. In the last decade a superficial pulse-peeling using it as agent in sequential applications was described. This modality of treatment has been demonstrated efficacy and better tolerability.
The improvement of the overall aspect of photodamaged skin is observed while treating multiple AKs.
There are no comparative study between the two types of 5% 5-FU use. So that is the purpose of our clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5% 5-fluoruracil cream | Active comparator | Drug: 5-fluoruracil30 patients will use 5% 5-fluoruracil cream, twice a day, during 3 weeks, in one randomized forearm |
| 5% 5-fluoruracil peeling | Active comparator | Procedure: 5-fluoruracilThe same 30 patients will be submitted to 4 applications of 5% 5-fluoruracil superficial peeling in the other forearm |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy Men and women, aged from 50 to 75 anos;
- Phototype I a III (Fitzpatrick Classification);
- Advanced photoaging on forearms, with multiple superficial actinic keratosis;
- Agreement with no sun exposure during the study and
- Agreement with study conditions,capacity to understand and follow the orientations and form consent signature.
Key exclusion criteria (10 listed)
- Topical treatment with:
- Treatment by chemical peeling, microdermabrasion and non-ablative laser in the last 3 months;
- Treatment with systemic retinoid in the last 6 months ;
- Chemotherapy in the last 3 months;
- Hypersensibility to parabens;
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 |
|---|---|---|
| 5-fluoruracilAlso: Topical treatment5% 5-fluoruracil cream, twice a day, during 3 weeks | Drug | 5% 5-fluoruracil cream |
| 5-fluoruracilAlso: Cosmetic procedureThe same 30 patients will be submitted to 4 weekly application of superficial peeling using 5% 5-fluoruracil in propyleneglycol as vehicle. The applications will be performed by physician (one of the co-investigators) | Procedure or surgery | 5% 5-fluoruracil peeling |
Primary outcome
Change in Photographic Evaluation
Time frame: 0, 60, 180 days
Photographic blinded evaluation by two independent observers, comparing modifications of forearms skin overall aspect before and after 60 and 180 days of the treatments. The following 5 point scale will be used: -2=much worse; -1=worse; 0=inlatered; 1=better, 2= much better
Change in Microscopic Evaluation
Time frame: 0, 180 days
Skin biopsies will be performed and coloration by hematoxilin-eosin, Verhoeff, Tricromio Masson , Picrosirius and biomarkers (p53, bcl2, collagen 1)will be used. The modifications on corneal layer and epidermal thickness, dermal elastotic material and collagen deposition and biomarkers expression will be evaluated by digital quantitative analysis, comparing the findings before (day 0) and after (day 180)treatments.
5 secondary outcomes
Inflammatory Skin Reaction
Time frame: 30 day
Occurence and Evaluation of Adverse Events
Time frame: 30, 60, 180 days
Change in Patient Opinion
Time frame: 0, 30, 60, 180 days
Change in Investigator Clinical Evaluation
Time frame: 0, 30, 60, 180 days
Change in Forearm Photoaging Classification
Time frame: 0, 60, 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2011.
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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.
Ediléia Bagatin, PhD study chair
Professor
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 5-fluoruracil in people with Photoaging and Actinic Keratosis, run by Federal University of São Paulo at 1 site in Brazil.
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 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: status not confirmed, as of the sponsor's last update on 29 Jul 2011. 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 Brazil. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edileia Bagatin, phD (55-11-94448848, edileia_bagatin@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Photographic Evaluation (time frame: 0, 60, 180 days). The study lists 2 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 29 Jul 2011.