A Comparative Study of Adapalene Gel,0.3% Versus Tretinoin Emollient Cream, 0.05% for the Treatment of Photoaging

Condition(s) targeted: Photoaging; Photodamage

Intervention: Adapalene (Drug); Tretinoin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Galderma Brasil Ltda.

Official(s) and/or principal investigator(s):
Alessandra Nogueira, Study Director, Affiliation: Galderma Brasil Lltda
Edileia Bagatin, Principal Investigator, Affiliation: Universidade Federal de São Paulo

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.

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.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Assessing the extent of Cutaneous Photoaging at the end of treatment.

Secondary outcome:

Global Assessment of photoaging, based on the Griffiths photonumeric scale.

Assessing the extent of Cutaneous Photoaging at each visit.

Evaluation of Improvement by the Investigator at Week 12

Evaluation of Improvement by the Investigator at Week 24

Subject Assessment of improvement at week 24.

Anatomical-pathological assessment

Digital morphometric assessment.

Minimum age: 35 Years. Maximum age: 55 Years. Gender(s): Both.

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;

Hospital das Clínicas da FMUSP, São Paulo 05403-000, Brazil; Not yet recruiting
Luiz Torezan, Email: torezanluis@uol.com.br

Universidade Federal de São Paulo - UNIFESP - UNICCO, São Paulo 04022-000, Brazil; Recruiting
Edileia Bagatin, Phone: +55 11 5549 7888, Email: unicco@terra.com.br
Ediléia Bagatin, Principal Investigator
Karime Hassun, Sub-Investigator
Sonia Lopes Beta Yamada, Sub-Investigator

Centro de Dermatologia Dona Libania, Fortaleza, Ceará 60035-101, Brazil; Recruiting
Maria Araci Pontes Aires, Phone: +55 85 3101 5431
Heitor de Sá Gonçalves, Principal Investigator
Maria Araci Pontes Aires, Sub-Investigator

Santa Casa de Belo Horizonte, Belo Horizonte, Minas Gerais 30150-221, Brazil; Recruiting
Luiz Mauricio Costa Almeida, Email: lmcalmeida@uol.com.br

Hospital de Clínicas da Universidade Federal do Paraná, Curitiba, Paraná 80060-900, Brazil; Recruiting
Mauricio Shigueru Sato, Email: mashmauricio@gmail.com
Gisele Padilha
Mauricio Shigueru Sato, Principal Investigator

Irmandade da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, Rio Grande do Sul 90020-090, Brazil; Recruiting
Célia Kalil, MD, Email: clpvkderma@via-rs.net

Starting date: January 2013
Last updated: January 22, 2013