PhotoagingPhase 2NCT00701740
Oral Isotretinoin for Photoaging: Results of a Randomized Controlled Phase II Trial
A Phase 2 study testing oral isotretinoin and Mexoryl SX / XL and Mexoryl XL / SX in people with Photoaging and Epidermal p53 Expression, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
A clinical and histological randomized controlled phase II trial to evaluate the efficacy and safety of oral isotretinoin for treating photoaging was performed with 32 menopausal or sterilized women aged 40-55y. Read more about this study
- Who is it for?
- Ages 40 to 55 years, women only
- Conditions the study is for
- Photoaging, Epidermal p53 Expression
- What is being tested?
- oral isotretinoin and Mexoryl SX / XL and Mexoryl XL / SX
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2007to Jun 2008
- 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 40 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- menopausal or sterilized women
Who cannot join
- woman at risk of pregnancy, with alterations on liver function or lipid profile
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Randomized Controlled Trial to Evaluate the Clinical and Histological Effects of Oral Isotretinoin for the Treatment of Photoaging on Face and Forearms
A clinical and histological randomized controlled phase II trial to evaluate the efficacy and safety of oral isotretinoin for treating photoaging was performed with 32 menopausal or sterilized women aged 40-55y. The subjects were included in two randomly selected groups: A- 21 women received 20mg oral isotretinoin 3x week, moisturizer, sunscreen SPF 60 during three months; B- 11 women received only same moisturizer/sunscreen.
Read the detailed description
Clinical assessment ranging from -2=very bad to +2=very good for all patients. Also, profilometry, corneometer and skin elasticity tests in periocular regions and left forearm; skin biopsy on left forearm before/after treatment in B and in 10 randomly selected patients from A. Microscopic evaluation of corneal layer and epidermal thickness, dermal elastosis, new collagen and p53 epidermal expression performed by quantitative digital image analysis. Blind evaluations (group/time) conducted by two independent observers.
Clinical evaluation results showed no alterations (0) or slight improvement (+1) for all patients; profilometry, corneometer and skin elasticity measurements presented a significant difference in pre and post treatment values (p=0,001 to 0,028) with no differences between A/B. Regarding histological findings and p53 expression no previous differences between groups before the treatment were observed (p>0,1).Quantitative microscopic digital analysis demonstrated no differences between groups at the end of the study for the majority of variables. However, slight but significant difference between A/B subjects was found for p53 with major expression reduction for those treated with oral isotretinoin [0,66±0,31 vs 0,94±0,34 respectively (p=0,04)]. The main side effects were cheilitis in 15 patients (75%) and xerophthalmia in 5 (25%). No significant alterations occurred in biochemical tests.
- Conditions
- Photoaging, Epidermal p53 Expression
- Being tested
- oral isotretinoin and Mexoryl SX / XL, Mexoryl XL / SX
- Keywords
- photoaging, isotretinoin, profilometry, digital analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral isotretinoin and Mexoryl SX / XLDrug
Also called isotretinoin, mexoryl
20mg, 3/week,continuously for three months
Mexoryl XL / SXDrug
Also called mexoryl
11 subjects used only the same moisturizer and SPF 60 sunscreen
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | A - 21 subjects were treated 20mg isotretinoin 3/week plus moisturizer and sunscreen,for three months; 10 randomly selected were submitted to skin biopsies before and after the end of treatment Receives: Drug: oral isotretinoin and Mexoryl SX / XL |
| B | Active comparator | 11 subjects received only the same moisturizer/sunscreen Receives: Drug: Mexoryl XL / SX |
What is being measured
The primary outcome is the main question the study is designed to answer.
histological findings
Measured: before and after 3 months
Secondary outcomes (1)
laboratory tests
Measured: before, after 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startJul 2007
- Primary completionJan 2008
- Study completionJun 2008
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edileia Bagatin, Federal University of São Paulo
- Investigators
- Edileia Bagatin, MD, PHD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00701740
- Sponsor's protocol ID
- UNIFESP
- Status last verified
- Aug 2018
- First submitted
- 18 Jun 2008
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Controlled Trial to Evaluate the Clinical and Histological Effects of Oral Isotretinoin for the Treatment of Photoaging on Face and Forearms
- ClinicalTrials.gov ID
- NCT00701740
- Acronym / sponsor ID
- UNIFESP
- Conditions
- Photoaging, Epidermal p53 Expression
- Keywords
- photoaging, isotretinoin, profilometry, digital analysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 19 Jun 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.
A clinical and histological randomized controlled phase II trial to evaluate the efficacy and safety of oral isotretinoin for treating photoaging was performed with 32 menopausal or sterilized women aged 40-55y. The subjects were included in two randomly selected groups: A- 21 women received 20mg oral isotretinoin 3x week, moisturizer, sunscreen SPF 60 during three months; B- 11 women received only same moisturizer/sunscreen.
Detailed description
Clinical assessment ranging from -2=very bad to +2=very good for all patients. Also, profilometry, corneometer and skin elasticity tests in periocular regions and left forearm; skin biopsy on left forearm before/after treatment in B and in 10 randomly selected patients from A. Microscopic evaluation of corneal layer and epidermal thickness, dermal elastosis, new collagen and p53 epidermal expression performed by quantitative digital image analysis. Blind evaluations (group/time) conducted by two independent observers.
Clinical evaluation results showed no alterations (0) or slight improvement (+1) for all patients; profilometry, corneometer and skin elasticity measurements presented a significant difference in pre and post treatment values (p=0,001 to 0,028) with no differences between A/B. Regarding histological findings and p53 expression no previous differences between groups before the treatment were observed (p>0,1).Quantitative microscopic digital analysis demonstrated no differences between groups at the end of the study for the majority of variables. However, slight but significant difference between A/B subjects was found for p53 with major expression reduction for those treated with oral isotretinoin [0,66±0,31 vs 0,94±0,34 respectively (p=0,04)]. The main side effects were cheilitis in 15 patients (75%) and xerophthalmia in 5 (25%). No significant alterations occurred in biochemical tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: oral isotretinoin and Mexoryl SX / XLA - 21 subjects were treated 20mg isotretinoin 3/week plus moisturizer and sunscreen,for three months; 10 randomly selected were submitted to skin biopsies before and after the end of treatment |
| B | Active comparator | Drug: Mexoryl XL / SX11 subjects received only the same moisturizer/sunscreen |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- menopausal or sterilized women
Key exclusion criteria (1 listed)
- woman at risk of pregnancy, with alterations on liver function or lipid profile
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 |
|---|---|---|
| oral isotretinoin and Mexoryl SX / XLAlso: isotretinoin, mexoryl20mg, 3/week,continuously for three months | Drug | A |
| Mexoryl XL / SXAlso: mexoryl11 subjects used only the same moisturizer and SPF 60 sunscreen | Drug | B |
Primary outcome
histological findings
Time frame: before and after 3 months
1 secondary outcome
laboratory tests
Time frame: before, after 1 and 3 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 15 Aug 2018.
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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.
Edileia Bagatin, MD, PHD principal investigator
Federal University of São Paulo
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 oral isotretinoin and Mexoryl SX / XL and Mexoryl XL / SX in people with Photoaging and Epidermal p53 Expression, 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 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 15 Aug 2018. 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 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?
histological findings (time frame: before and after 3 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 15 Aug 2018.