PhotoagingPhase 3FOTENNCT01406080
A Comparative Study of Adapalene Gel,0.3% Versus Tretinoin Emollient Cream, 0.05% for the Treatment of Photoaging
A Phase 3 study testing Adapalene and Tretinoin in people with Photoaging and Photodamage, run by Galderma Brasil Ltda. at 4 sites in Brazil.
Trial summary
The purpose of this study is to: 1. Evaluate the efficacy of Adapalene gel 0.3% compared to Tretinoin Emollient cream 0.05%, reducing signs of cutaneous photoageing, measured trough photonumeric scale evaluation, investigator evaluation of global response to treatment and subject's evaluation of improvement. 2. Read more about this study
- Who is it for?
- Ages 35 to 55 years
- Conditions the study is for
- Photoaging, Photodamage
- What is being tested?
- Adapalene and Tretinoin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 4 sitesBrazil
- Study dates
- Jan 2013to Nov 2015
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients presenting at least some score on periorbital or frontal wrinkle or melanosis and at maximum a "Severe" score on any of the criteria considered in evaluating cutaneous photoaging extension, based on the table for assessing Cutaneous Photoaging Extent;
- Male and female patients aged at least 35 years and maximum of 55 years, with skin phototype of I to IV, according to the T.B. Fitzpatrick's scale;
- Individuals who have mild to moderate cutaneous photoaging, i.e., score 2-6 in the overall assessment of cutaneous photoaging, based on the Griffiths scale;
- If female, individuals who cannot get pregnant (defined as post-menopausal the lack of menstrual bleeding for one year - or have undergone bilateral tubal ligation, hysterectomy or bilateral oophorectomy) or, if in childbearing age, patients who underwent urine pregnancy test with negative results. Patients should be using an appropriate contraceptive method. In the case of oral contraceptives, the use must have been started at least one month before the study or 12 months in case of pills containing cyproterone. Patients should maintain the same contraceptive during the study and 1 additional month after completion;
- For subjects under treatment for a concomitant medical condition, type and dose must be stable for at least three months prior to study entry (at least one year, in the case of hormone replacement therapy) and should not change during the study. These drugs do not include the excluded drugs cited in exclusion criterion;
- Individuals able to avoid prolonged sun exposure, especially on the face during the study period and willing to use the proper techniques to avoid the sun, including the use of sunscreen provided during the study;
- Individuals able to follow the study instructions and who are willing to complete all required visits;
- Individuals who have signed the informed consent form before any study procedures;
Who cannot join
- Patients who have participated in another clinical trial for less than 30 days;
- Pregnant women, nursing mothers or women attempting to conceive;
- Female patients who started hormone replacement therapy for less than one year before entering the study;
- Individuals with a condition or who are in a situation that, in the opinion of the investigator, may put the objective of the study at risk, confound the results or even interfere with the individual participation. These include, but are not limited to:
- Individuals with other facial skin disorders or dermatosis (scars, inflammatory acne, etc.) that can interfere with the clinical evaluation;
- Patients with a history of treatment for photoaging using ablative laser technologies (such as carbon dioxide and Erbium: YAG) and / or non-ablative (Nd: YAG, Fractionated Erbium Glass, Diode, Infrared Light, Intense Pulsed Light, Radiofrequency, Pulsed Dye Laser), dermabrasion, medium or deep chemical peeling on face;
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- Individuals diagnosed with skin cancer (squamous cell carcinoma, melanoma) in the last 3 months prior to study entry;
- Individuals not willing to refrain from any cosmetic procedure during the study period (e.g. other types of chemical peelings, microdermabrasion, etc.);
- Individuals with significant medical history, concomitant disease or condition in which the investigator believes that participation in the study is not propitious;
- Patients with known sensitivity to retinoids or to any component of the study products;
- Patients with a diagnosis or history of keloids;
- Patients without the minimum wash-out period for the following treatments:
- 2 weeks for topical alpha- hydroxy acid, glycolic acid, salicylic acid, lactic acid, betahydroxy acid on the face.
- 2 weeks for topical products containing vitamin A, ascorbic acid, vitamin E on the face.
- 2 weeks for topical corticosteroids.
- 4 weeks for systemic corticosteroids.
- 3 months for topical retinoids.
- 1 year for oral retinoids.
- Patients who underwent superficial chemical peelings, microdermabrasion or exfoliation on the face in the last 3 months;
- Patients who applied botulinum toxin or soft tissue fillers for facial rejuvenation in the last 6 months and do not agree on not using these products during the study;
- Patients self-identified as "sensitive skin";
- Patients who are not willing or able to attend the study visits;
Trial locations and contacts
4 sites in 1 country.
Brazil4 sites
Santa Casa de Belo Horizonte
Belo Horizonte, Minas Gerais, 30150-221
Hospital de Clínicas da Universidade Federal do Paraná
Curitiba, Paraná, 80060-900
Centro de Dermatologia Dona Libania
Fortaleza, Ceará, 60035-101
Universidade Federal de São Paulo - UNIFESP - UNICCO
São Paulo, São Paulo, 04022-000
About this study
Official title: Single-blinded, Multicenter, Randomized, Comparative Study of Efficacy and Safety of Adapalene Gel 0.3% Versus Tretinoin Emollient Cream 0.05% in the Treatment of Cutaneous Photoaging.
The purpose of this study is to:
- Evaluate the efficacy of Adapalene gel 0.3% compared to Tretinoin Emollient cream 0.05%, reducing signs of cutaneous photoageing, measured trough photonumeric scale evaluation, investigator evaluation of global response to treatment and subject's evaluation of improvement.
- Evaluate the safety and tolerability of Adapalene Gel 0.3%, compared to Tretinoin Emollient cream 0.05% during 24 weeks of treatment.
The study has the clinical hypothesis that Adapalene Gel 0.3% is as effective as Tretinoin Emollient cream 0.05% in the treatment of cutaneous photoaging.
- Conditions
- Photoaging, Photodamage
- Being tested
- Adapalene, Tretinoin
- Keywords
- Photoaging, Photodamage, Adapalene, Differin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdapaleneDrug
Also called Differin® Gel 0.3%, Adapalene Gel 0.3%
Apply approximately 1 gram of Differin 0.3% every night on the entire face, except near the eye region.
TretinoinDrug
Also called Tretinoin emollient cream 0,05%
Apply approximately 1 gram of Tretinoin emollient cream 0.05% every night on the entire face, except near the eye region.
| Study group | Role | What they receive |
|---|---|---|
| Adapalene | Active comparator | Differin® gel 0.3% (adapalene Gel 0,3%) Receives: Drug: Adapalene |
| Tretinoin | Active comparator | Tretinoin 0,05% emollient cream Receives: Drug: Tretinoin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the extent of Cutaneous Photoaging at the end of treatment.
Evaluation of Cutaneous Photoaging Extension at the end of treatment: the signs of cutaneous photoaging are evaluated by means of reduction of at least one point in any one of the following parameters: periorbital wrinkles, ephelides / melanosis, forehead wrinkles, tactile roughness (texture) and actinic keratosis.
Measured: Baseline to week 24
Secondary outcomes (7)
Global Assessment of photoaging, based on the Griffiths photonumeric scale.
The evaluator, blinded to the treatment, will assess the global degree of photoaging of the patient in all visits, based on photographic images of the Griffiths scale consisted of 5 categories (Periorbital Wrinkles, Ephelides / melanosis, Forehead Wrinkles, Tactile roughness (texture), Actinic Keratosis. These were evaluated on a scale from 0 - 4 (0 = Absent, 1 = Minimal, 2 = Mild, 3 = Moderate and 4 = Severe) with 0 being best and 4 being worst.
Measured: week 24
Assessing the extent of Cutaneous Photoaging at each visit.
The absolute values and changes of the Evaluation of Cutaneous Photoaging Extent in relation to baseline will be summarized by using frequency tables and at each visit and the groups will be compared.
Measured: week 24
Evaluation of Improvement by the Investigator at Week 12
The evaluator, blinded to the treatment, will evaluate the improvement of the photoaging signs at week 12 using the scale 5 = important response, 4 = near complete response (≈ 90% improvement), 3 = marked response (≈ 75% improvement), 2 = moderate response (≈ 50% improvement), 1 = mild response (≈ 25% improvement), 0 = No answer, -1= Worsening.
Measured: week 12
Evaluation of Improvement by the Investigator at Week 24
The evaluator, blinded to the treatment, will evaluate the improvement of the photoaging signs at week 12 using the scale 5 = important response, 4 = near complete response (≈ 90% improvement), 3 = marked response (≈ 75% improvement), 2 = moderate response (≈ 50% improvement), 1 = mild response (≈ 25% improvement), 0 = No answer, -1= Worsening.
Measured: Week 24
Subject Assessment of improvement at week 24.
Patients will evaluate the improvement perceived at week 24 using the following scale:0 = Improves hard to notice, 1 = A very small improvement, 2 = Small improvement, 3 = Moderate improvement, 4 = Major improvements.
Measured: week 24
Anatomical-pathological assessment
The difference between the treatment arms in epidermal thickness and 7.7 in the thickness of the granular layer will be detect at week 24.
Measured: week 24
Digital morphometric assessment.
The thickness of the stratum corneum, granular layer and the epithelium will be estimated
Measured: week 24
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 startJan 2013
- Primary completionNov 2015
- Study completionNov 2015
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma Brasil Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ananda Quadros Campos, Study director, Galderma Brasil LltdaEdileia Bagatin, Principal investigator, Universidade Federal de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406080
- Sponsor's protocol ID
- BR.10.002
- Acronym
- FOTEN
- Status last verified
- Jan 2016
- First submitted
- 28 Jul 2011
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-blinded, Multicenter, Randomized, Comparative Study of Efficacy and Safety of Adapalene Gel 0.3% Versus Tretinoin Emollient Cream 0.05% in the Treatment of Cutaneous Photoaging.
- ClinicalTrials.gov ID
- NCT01406080
- Acronym / sponsor ID
- FOTEN / BR.10.002
- Conditions
- Photoaging, Photodamage
- Keywords
- Photoaging, Photodamage, Adapalene, Differin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Galderma Brasil Ltda.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- 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.
The purpose of this study is to:
- Evaluate the efficacy of Adapalene gel 0.3% compared to Tretinoin Emollient cream 0.05%, reducing signs of cutaneous photoageing, measured trough photonumeric scale evaluation, investigator evaluation of global response to treatment and subject's evaluation of improvement.
- Evaluate the safety and tolerability of Adapalene Gel 0.3%, compared to Tretinoin Emollient cream 0.05% during 24 weeks of treatment.
The study has the clinical hypothesis that Adapalene Gel 0.3% is as effective as Tretinoin Emollient cream 0.05% in the treatment of cutaneous photoaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adapalene | Active comparator | Drug: AdapaleneDifferin® gel 0.3% (adapalene Gel 0,3%) |
| Tretinoin | Active comparator | Drug: TretinoinTretinoin 0,05% emollient cream |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients presenting at least some score on periorbital or frontal wrinkle or melanosis and at maximum a "Severe" score on any of the criteria considered in evaluating cutaneous photoaging extension, based on the table for assessing Cutaneous Photoaging Extent;
- Male and female patients aged at least 35 years and maximum of 55 years, with skin phototype of I to IV, according to the T.B. Fitzpatrick's scale;
- Individuals who have mild to moderate cutaneous photoaging, i.e., score 2-6 in the overall assessment of cutaneous photoaging, based on the Griffiths scale;
- If female, individuals who cannot get pregnant (defined as post-menopausal the lack of menstrual bleeding for one year - or have undergone bilateral tubal ligation, hysterectomy or bilateral oophorectomy) or, if in childbearing age, patients who underwent urine pregnancy test with negative results. Patients should be using an appropriate contraceptive method. In the case of oral contraceptives, the use must have been started at least one month before the study or 12 months in case of pills containing cyproterone. Patients should maintain the same contraceptive during the study and 1 additional month after completion;
- For subjects under treatment for a concomitant medical condition, type and dose must be stable for at least three months prior to study entry (at least one year, in the case of hormone replacement therapy) and should not change during the study. These drugs do not include the excluded drugs cited in exclusion criterion;
Key exclusion criteria (22 listed)
- Patients who have participated in another clinical trial for less than 30 days;
- Pregnant women, nursing mothers or women attempting to conceive;
- Female patients who started hormone replacement therapy for less than one year before entering the study;
- Individuals with a condition or who are in a situation that, in the opinion of the investigator, may put the objective of the study at risk, confound the results or even interfere with the individual participation. These include, but are not limited to:
- Patients with known sensitivity to retinoids or to any component of the study products;
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 |
|---|---|---|
| AdapaleneAlso: Differin® Gel 0.3%, Adapalene Gel 0.3%Apply approximately 1 gram of Differin 0.3% every night on the entire face, except near the eye region. | Drug | Adapalene |
| TretinoinAlso: Tretinoin emollient cream 0,05%Apply approximately 1 gram of Tretinoin emollient cream 0.05% every night on the entire face, except near the eye region. | Drug | Tretinoin |
Primary outcome
Assessing the extent of Cutaneous Photoaging at the end of treatment.
Time frame: Baseline to week 24
Evaluation of Cutaneous Photoaging Extension at the end of treatment: the signs of cutaneous photoaging are evaluated by means of reduction of at least one point in any one of the following parameters: periorbital wrinkles, ephelides / melanosis, forehead wrinkles, tactile roughness (texture) and actinic keratosis.
7 secondary outcomes
Global Assessment of photoaging, based on the Griffiths photonumeric scale.
Time frame: week 24
Assessing the extent of Cutaneous Photoaging at each visit.
Time frame: week 24
Evaluation of Improvement by the Investigator at Week 12
Time frame: week 12
Evaluation of Improvement by the Investigator at Week 24
Time frame: Week 24
Subject Assessment of improvement at week 24.
Time frame: week 24
Anatomical-pathological assessment
Time frame: week 24
Digital morphometric assessment.
Time frame: week 24
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 6 Apr 2017.
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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.
Ananda Quadros Campos study director
Galderma Brasil Lltda
Edileia Bagatin principal investigator
Universidade Federal de São Paulo
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adapalene and Tretinoin in people with Photoaging and Photodamage, run by Galderma Brasil Ltda. at 4 sites 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 8 inclusion and 22 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 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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?
Assessing the extent of Cutaneous Photoaging at the end of treatment. (time frame: Baseline to week 24). 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 6 Apr 2017.