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

NCT01406080 | Completed Phase 3 DMC

• 1 other identifier: BR.10.002
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to:

1. 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. 2.Evaluate the safety and tolerability of Adapalene Gel 0.3%, compared to Tretinoin Emollient cream 0.05% during 24 weeks of treatment.

Conditions

Photoaging; Photodamage

Keywords

Photoaging; Photodamage; Adapalene; Differin

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to week 24

Secondary Outcomes (7)

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

  week 24

• Assessing the extent of Cutaneous Photoaging at each visit.

  week 24

• Evaluation of Improvement by the Investigator at Week 12

  week 12

• Evaluation of Improvement by the Investigator at Week 24

  Week 24

• Subject Assessment of improvement at week 24.

  week 24

Study Arms (2)

Adapalene

ACTIVE COMPARATOR

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

Drug: Adapalene

Tretinoin

ACTIVE COMPARATOR

Tretinoin 0,05% emollient cream

Drug: Tretinoin

Interventions

Adapalene DRUG

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

Also known as: Differin® Gel 0.3%, Adapalene Gel 0.3%

Adapalene

Tretinoin DRUG

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

Also known as: Tretinoin emollient cream 0,05%

Tretinoin

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• 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;

You may not qualify if:

• 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:
• Individuals with other facial skin disorders or dermatosis (scars, inflammatory acne, etc.) that can interfere with the clinical evaluation;
• 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;
• Individuals diagnosed with skin cancer (squamous cell carcinoma, melanoma) in the last 3 months prior to study entry;
• Individuals not willing to refrain from any cosmetic procedure during the study period (e.g. other types of chemical peelings, microdermabrasion, etc.);
• 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:
• weeks for topical alpha- hydroxy acid, glycolic acid, salicylic acid, lactic acid, betahydroxy acid on the face.
• weeks for topical products containing vitamin A, ascorbic acid, vitamin E on the face.
• weeks for topical corticosteroids.

Sponsors & Collaborators

• Galderma Brasil Ltda.: lead

Study Sites (4)

Centro de Dermatologia Dona Libania

Fortaleza, Ceará, 60035-101, Brazil

Location

Santa Casa de Belo Horizonte

Belo Horizonte, Minas Gerais, 30150-221, Brazil

Location

Hospital de Clínicas da Universidade Federal do Paraná

Curitiba, Paraná, 80060-900, Brazil

Location

Universidade Federal de São Paulo - UNIFESP - UNICCO

São Paulo, São Paulo, 04022-000, Brazil

Location

MeSH Terms

Interventions

Adapalene; Tretinoin

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Officials

• Ananda Quadros Campos

  Galderma Brasil Lltda

  STUDY DIRECTOR

• Edileia Bagatin

  Universidade Federal de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2011
• First Posted: July 29, 2011
• Study Start: January 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: April 6, 2017

Record last verified: 2016-01

Locations

BR (4)