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

NCT ID: NCT01406080

Last Updated: 2017-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-11-30

Brief Summary

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.

Conditions

Photoaging; Photodamage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Adapalene

Differin® gel 0.3% (adapalene Gel 0,3%)

Group Type: ACTIVE_COMPARATOR

Adapalene

Intervention Type: DRUG

Apply approximately 1 gram of Differin 0.3% every night on the entire face, except near the eye region.

Tretinoin

Tretinoin 0,05% emollient cream

Group Type: ACTIVE_COMPARATOR

Tretinoin

Intervention Type: DRUG

Apply approximately 1 gram of Tretinoin emollient cream 0.05% every night on the entire face, except near the eye region.

Interventions

Adapalene

Apply approximately 1 gram of Differin 0.3% every night on the entire face, except near the eye region.

Intervention Type: DRUG

Tretinoin

Apply approximately 1 gram of Tretinoin emollient cream 0.05% every night on the entire face, except near the eye region.

Intervention Type: DRUG

Other Intervention Names

Differin® Gel 0.3%; Adapalene Gel 0.3%; Tretinoin emollient cream 0,05%

Eligibility 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;

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galderma Brasil Ltda.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ananda Quadros Campos

Role: STUDY_DIRECTOR

Galderma Brasil Lltda

Edileia Bagatin

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de São Paulo

Locations

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

Countries

Brazil

Other Identifiers

BR.10.002

Identifier Type: -

Identifier Source: org_study_id