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. 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
128
Apply approximately 1 gram of Differin 0.3% every night on the entire face, except near the eye region.
Apply approximately 1 gram of Tretinoin emollient cream 0.05% every night on the entire face, except near the eye region.
Centro de Dermatologia Dona Libania
Fortaleza, Ceará, Brazil
Santa Casa de Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil
Hospital de Clínicas da Universidade Federal do Paraná
Curitiba, Paraná, Brazil
Universidade Federal de São Paulo - UNIFESP - UNICCO
São Paulo, São Paulo, Brazil
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.
Time frame: Baseline to week 24
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: week 24
Digital morphometric assessment.
The thickness of the stratum corneum, granular layer and the epithelium will be estimated
Time frame: week 24
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