A Comparative Study of Adapalene Gel,0.3% Versus Tretinoin Emollient Cream, 0.05% for the Treatment of Photoaging (FOTEN)
This study is currently recruiting participants.
Verified January 2013 by Galderma Brasil Ltda.
Galderma Brasil Ltda.
Information provided by (Responsible Party):
Galderma Brasil Ltda.
First received: July 28, 2011
Last updated: January 22, 2013
Last verified: January 2013
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:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|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.|
Resource links provided by NLM:
Further study details as provided by Galderma Brasil Ltda.:
Primary Outcome Measures:
- Assessing the extent of Cutaneous Photoaging at the end of treatment. [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Global Assessment of photoaging, based on the Griffiths photonumeric scale. [ Time Frame: week 24 ] [ Designated as safety issue: No ]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.
- Assessing the extent of Cutaneous Photoaging at each visit. [ Time Frame: week 24 ] [ Designated as safety issue: No ]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.
- Evaluation of Improvement by the Investigator at Week 12 [ Time Frame: week 12 ] [ Designated as safety issue: No ]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.
- Evaluation of Improvement by the Investigator at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]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.
- Subject Assessment of improvement at week 24. [ Time Frame: week 24 ] [ Designated as safety issue: No ]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.
- Anatomical-pathological assessment [ Time Frame: week 24 ] [ Designated as safety issue: No ]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.
- Digital morphometric assessment. [ Time Frame: week 24 ] [ Designated as safety issue: No ]The thickness of the stratum corneum, granular layer and the epithelium will be estimated
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||November 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Adapalene
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.
Active Comparator: Tretinoin
Tretinoin 0,05% emollient cream
Apply approximately 1 gram of Tretinoin emollient cream 0.05% every night on the entire face, except near the eye region.
Other Name: Tretinoin emollient cream 0,05%
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01406080
|Centro de Dermatologia Dona Libania||Recruiting|
|Fortaleza, Ceará, Brazil, 60035-101|
|Contact: Maria Araci Pontes Aires +55 85 3101 5431|
|Principal Investigator: Heitor de Sá Gonçalves|
|Sub-Investigator: Maria Araci Pontes Aires|
|Santa Casa de Belo Horizonte||Recruiting|
|Belo Horizonte, Minas Gerais, Brazil, 30150-221|
|Contact: Luiz Mauricio Costa Almeida email@example.com|
|Hospital de Clínicas da Universidade Federal do Paraná||Recruiting|
|Curitiba, Paraná, Brazil, 80060-900|
|Contact: Mauricio Shigueru Sato firstname.lastname@example.org|
|Contact: Gisele Padilha|
|Principal Investigator: Mauricio Shigueru Sato|
|Irmandade da Santa Casa de Misericórdia de Porto Alegre||Recruiting|
|Porto Alegre, Rio Grande do Sul, Brazil, 90020-090|
|Contact: Célia Kalil, MD email@example.com|
|Universidade Federal de São Paulo - UNIFESP - UNICCO||Recruiting|
|São Paulo, Brazil, 04022-000|
|Contact: Edileia Bagatin +55 11 5549 7888 firstname.lastname@example.org|
|Principal Investigator: Ediléia Bagatin|
|Sub-Investigator: Karime Hassun|
|Sub-Investigator: Sonia Lopes Beta Yamada|
|Hospital das Clínicas da FMUSP||Not yet recruiting|
|São Paulo, Brazil, 05403-000|
|Contact: Luiz Torezan email@example.com|
Sponsors and Collaborators
Galderma Brasil Ltda.
|Study Director:||Alessandra Nogueira||Galderma Brasil Lltda|
|Principal Investigator:||Edileia Bagatin||Universidade Federal de São Paulo|