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The purpose of this study is to:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adapalene | Active Comparator | Differin® gel 0.3% (adapalene Gel 0,3%) |
|
| Tretinoin | Active Comparator | Tretinoin 0,05% emollient cream |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapalene | Drug | Apply approximately 1 gram of Differin 0.3% every night on the entire face, except near the eye region. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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;
Patients with a diagnosis or history of keloids;
Patients without the minimum wash-out period for the following treatments:
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;
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| Name | Affiliation | Role |
|---|---|---|
| Ananda Quadros Campos | Galderma Brasil Lltda | Study Director |
| Edileia Bagatin | Universidade Federal de São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Dermatologia Dona Libania | Fortaleza | Ceará | 60035-101 | Brazil | ||
| Santa Casa de Belo Horizonte |
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| ID | Term |
|---|---|
| D000068816 | Adapalene |
| D014212 | Tretinoin |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Tretinoin | Drug | Apply approximately 1 gram of Tretinoin emollient cream 0.05% every night on the entire face, except near the eye region. |
|
|
| 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. | 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. | 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. | 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. | 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. | week 24 |
| Digital morphometric assessment. | The thickness of the stratum corneum, granular layer and the epithelium will be estimated | week 24 |
| Belo Horizonte |
| Minas Gerais |
| 30150-221 |
| Brazil |
| Hospital de Clínicas da Universidade Federal do Paraná | Curitiba | Paraná | 80060-900 | Brazil |
| Universidade Federal de São Paulo - UNIFESP - UNICCO | São Paulo | São Paulo | 04022-000 | Brazil |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D014801 | Vitamin A |
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D013729 | Terpenes |
| D004224 | Diterpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |