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.
Sponsor:
Information provided by (Responsible Party):
Galderma Brasil Ltda.
ClinicalTrials.gov Identifier:
NCT01406080
First received: July 28, 2011
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Photoaging
Photodamage
Drug: Adapalene
Drug: Tretinoin
Phase 3

Study Type: Interventional
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


Estimated Enrollment: 120
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)
Arms Assigned Interventions
Active Comparator: Adapalene
Differin® gel 0.3% (adapalene Gel 0,3%)
Drug: Adapalene
Apply approximately 1 gram of Differin 0.3% every night on the entire face, except near the eye region.
Other Names:
  • Differin® Gel 0.3%
  • Adapalene Gel 0.3%
Active Comparator: Tretinoin
Tretinoin 0,05% emollient cream
Drug: Tretinoin
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%

  Eligibility

Ages Eligible for Study:   35 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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;

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:

    1. Individuals with other facial skin disorders or dermatosis (scars, inflammatory acne, etc.) that can interfere with the clinical evaluation;
    2. 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;
    3. Individuals diagnosed with skin cancer (squamous cell carcinoma, melanoma) in the last 3 months prior to study entry;
    4. Individuals not willing to refrain from any cosmetic procedure during the study period (e.g. other types of chemical peelings, microdermabrasion, etc.);
    5. 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:

    1. 2 weeks for topical alpha- hydroxy acid, glycolic acid, salicylic acid, lactic acid, betahydroxy acid on the face.
    2. 2 weeks for topical products containing vitamin A, ascorbic acid, vitamin E on the face.
    3. 2 weeks for topical corticosteroids.
    4. 4 weeks for systemic corticosteroids.
    5. 3 months for topical retinoids.
    6. 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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01406080

Locations
Brazil
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       lmcalmeida@uol.com.br   
Hospital de Clínicas da Universidade Federal do Paraná Recruiting
Curitiba, Paraná, Brazil, 80060-900
Contact: Mauricio Shigueru Sato       mashmauricio@gmail.com   
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       clpvkderma@via-rs.net   
Universidade Federal de São Paulo - UNIFESP - UNICCO Recruiting
São Paulo, Brazil, 04022-000
Contact: Edileia Bagatin    +55 11 5549 7888    unicco@terra.com.br   
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       torezanluis@uol.com.br   
Sponsors and Collaborators
Galderma Brasil Ltda.
Investigators
Study Director: Alessandra Nogueira Galderma Brasil Lltda
Principal Investigator: Edileia Bagatin Universidade Federal de São Paulo
  More Information

No publications provided

Responsible Party: Galderma Brasil Ltda.
ClinicalTrials.gov Identifier: NCT01406080     History of Changes
Other Study ID Numbers: BR.10.002
Study First Received: July 28, 2011
Last Updated: January 22, 2013
Health Authority: Brazil: Ethics Committee
Brazil: National Health Surveillance Agency

Keywords provided by Galderma Brasil Ltda.:
Photoaging
Photodamage
Adapalene
Differin

Additional relevant MeSH terms:
Tretinoin
Skin Diseases
Emollients
Adapalene
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents
Keratolytic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014