PhotodamagePhase 2NCT00842907
Efficacy and Safety of Oral Isotretinoin for Cutaneous Photodamage
A Phase 2 study testing oral isotretinoin and Tretinoin in people with Photodamage and Photoaging, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
This is a randomized, comparative, single evaluator-blinded trial to evaluate clinical, histological and immunohistochemical effects of oral isotretinoin plus moisturizer sunscreen as compared to the use of 0,05% tretinoin cream plus moisturizer sunscreen for the treatment of photodamage on face and forearms. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Photodamage, Photoaging
- What is being tested?
- oral isotretinoin and Tretinoin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- May 2009to Aug 2010
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged from 50 to 75 years old
- Post-menopausal women for at least one year
- Patients with moderate to severe photodamage on face and arms
- Individuals in generally good health
- Fitzpatrick I to III skin type
- Patients who are willing to avoid sun-exposure during the study period
Who cannot join
- Patients of child bearing potential
- Individuals who have been treated with topical anti-aging products and/or superficial chemical peels within 3 months or received topical tretinoin or oral retinoid (6 months); fillers and/or botulinum toxin applications (4 months); medium-depth chemical peels or ablative lasers or dermabrasion (6 months) and surgical lifting (12 months) will not be eligible for inclusion in the study
- Patients on cytotoxic drugs (including azathioprine, cyclophosphamide, mycophenolate mofetil, or other chemotherapeutic agents) within 3 months
- Hypersensitivity to parabens
- An infectious or inflammatory dermatosis of the face, scalp or forearms including acne rosacea
- A history of photodermatosis (example PMLE)
Show all 9Show fewer
- Immunocompromised individuals
- Patients with auto-immune diseases
- Patients addicted to drugs or alcohol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical, Laboratorial and Quality of Life Study to Evaluate the Efficacy and Safety of Oral Isotretinoin in the Treatment of Cutaneous Photodamage
This is a randomized, comparative, single evaluator-blinded trial to evaluate clinical, histological and immunohistochemical effects of oral isotretinoin plus moisturizer sunscreen as compared to the use of 0,05% tretinoin cream plus moisturizer sunscreen for the treatment of photodamage on face and forearms. Main oral isotretinoin safety parameters will also be analyzed, as well as adverse events related to topical products.
Read the detailed description
A 24-week study, with 7 or 9 monthly visits, comprising healthy adult volunteers, aged 50 to 75 years will be carried out. The patients should present advanced to severe photodamage on face and forearms. Written informed consent will be obtained from each subject prior to enrollment.
Eligible patients will be randomly divided in two groups:
A- 10 patients will be treated with oral isotretinoin, 20.0 mg/day, every other day, 15 capsules per month, for 24 weeks, associated with the use of moisturizer broad spectrum sunscreen twice a day.
B- 10 patients (controls) will be treated with 0,05% tretinoin cream applied on face and forearms at night and the same moisturizer broad-spectrum sunscreen twice a day.
After randomization, laboratory tests will be requested for patients from group A and will be repeated on weeks 4 and 24.
- Conditions
- Photodamage, Photoaging
- Being tested
- oral isotretinoin, Tretinoin
- Keywords
- Brazil, isotretinoin, photodamage, photoaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral isotretinoinDrug
Also called oral retinoid
one 20.0 mg capsule, once a day, every other day, during 24 weeks
TretinoinDrug
Also called topical retinoid, topical tretinoin, topical retinoic acid
0.05% tretinoin cream applied on face and forearms, once a day, in the night, during 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| oral isotretinoin | Active comparator | Twelve subjects will be treated with oral isotretinoin 20.0 mg, once a day, every other day, for 24 weeks. Receives: Drug: oral isotretinoin |
| tretinoin | Active comparator | Twelve patients will be treated with 0,05% tretinoin cream applied on face and forearms at night and moisturizer broad-spectrum sunscreen twice a day. Receives: Drug: Tretinoin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical, histological and immunohistochemical features before and after treatments
Measured: 24 weeks
Secondary outcomes (1)
Quality of life
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2009 (estimated)
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Edileia Bagatin, MD, PhD, Principal investigator, Federal University of Sao Paulo, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842907
- Sponsor's protocol ID
- UNICCO
- Status last verified
- Apr 2009
- First submitted
- 11 Feb 2009
- Last updated
- 8 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical, Laboratorial and Quality of Life Study to Evaluate the Efficacy and Safety of Oral Isotretinoin in the Treatment of Cutaneous Photodamage
- ClinicalTrials.gov ID
- NCT00842907
- Acronym / sponsor ID
- UNICCO
- Conditions
- Photodamage, Photoaging
- Keywords
- Brazil, isotretinoin, photodamage, photoaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 12 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.
This is a randomized, comparative, single evaluator-blinded trial to evaluate clinical, histological and immunohistochemical effects of oral isotretinoin plus moisturizer sunscreen as compared to the use of 0,05% tretinoin cream plus moisturizer sunscreen for the treatment of photodamage on face and forearms. Main oral isotretinoin safety parameters will also be analyzed, as well as adverse events related to topical products.
Detailed description
A 24-week study, with 7 or 9 monthly visits, comprising healthy adult volunteers, aged 50 to 75 years will be carried out. The patients should present advanced to severe photodamage on face and forearms. Written informed consent will be obtained from each subject prior to enrollment.
Eligible patients will be randomly divided in two groups:
A- 10 patients will be treated with oral isotretinoin, 20.0 mg/day, every other day, 15 capsules per month, for 24 weeks, associated with the use of moisturizer broad spectrum sunscreen twice a day.
B- 10 patients (controls) will be treated with 0,05% tretinoin cream applied on face and forearms at night and the same moisturizer broad-spectrum sunscreen twice a day.
After randomization, laboratory tests will be requested for patients from group A and will be repeated on weeks 4 and 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral isotretinoin | Active comparator | Drug: oral isotretinoinTwelve subjects will be treated with oral isotretinoin 20.0 mg, once a day, every other day, for 24 weeks. |
| tretinoin | Active comparator | Drug: TretinoinTwelve patients will be treated with 0,05% tretinoin cream applied on face and forearms at night and moisturizer broad-spectrum sunscreen twice a day. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged from 50 to 75 years old
- Post-menopausal women for at least one year
- Patients with moderate to severe photodamage on face and arms
- Individuals in generally good health
- Fitzpatrick I to III skin type
Key exclusion criteria (9 listed)
- Patients of child bearing potential
- Individuals who have been treated with topical anti-aging products and/or superficial chemical peels within 3 months or received topical tretinoin or oral retinoid (6 months); fillers and/or botulinum toxin applications (4 months); medium-depth chemical peels or ablative lasers or dermabrasion (6 months) and surgical lifting (12 months) will not be eligible for inclusion in the study
- Patients on cytotoxic drugs (including azathioprine, cyclophosphamide, mycophenolate mofetil, or other chemotherapeutic agents) within 3 months
- Hypersensitivity to parabens
- An infectious or inflammatory dermatosis of the face, scalp or forearms including acne rosacea
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 isotretinoinAlso: oral retinoidone 20.0 mg capsule, once a day, every other day, during 24 weeks | Drug | oral isotretinoin |
| TretinoinAlso: topical retinoid, topical tretinoin, topical retinoic acid0.05% tretinoin cream applied on face and forearms, once a day, in the night, during 24 weeks | Drug | tretinoin |
Primary outcome
Clinical, histological and immunohistochemical features before and after treatments
Time frame: 24 weeks
1 secondary outcome
Quality of life
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2010.
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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 Sao Paulo, Brazil
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 Tretinoin in people with Photodamage and Photoaging, 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 6 inclusion and 9 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 8 Jun 2010. 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?
Results are not available in the source record.
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?
Clinical, histological and immunohistochemical features before and after treatments (time frame: 24 weeks). 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 8 Jun 2010.