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

Sponsor

Galderma Brasil Ltda. (Industry)

Overall Status

Completed

CT.gov ID

NCT01406080

Collaborator

(none)

128

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Photoaging Photodamage	Drug: Adapalene Drug: Tretinoin	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

128 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (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.

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Nov 1, 2015

Actual Study Completion Date :

Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Tretinoin emollient cream 0,05%

Arm

Intervention/Treatment

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 Names:

Tretinoin emollient cream 0,05%

Outcome Measures

Primary Outcome Measures

Assessing the extent of Cutaneous Photoaging at the end of treatment. [Baseline to week 24]
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. [week 24]
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. [week 24]
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 [week 12]
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 [Week 24]
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. [week 24]
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 [week 24]
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. [week 24]
The thickness of the stratum corneum, granular layer and the epithelium will be estimated

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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:

2 weeks for topical alpha- hydroxy acid, glycolic acid, salicylic acid, lactic acid, betahydroxy acid on the face.
2 weeks for topical products containing vitamin A, ascorbic acid, vitamin E on the face.
2 weeks for topical corticosteroids.
4 weeks for systemic corticosteroids.
3 months for topical retinoids.
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

Locations

	Site	City	State	Country	Postal Code
1	Centro de Dermatologia Dona Libania	Fortaleza	Ceará	Brazil	60035-101
2	Santa Casa de Belo Horizonte	Belo Horizonte	Minas Gerais	Brazil	30150-221
3	Hospital de Clínicas da Universidade Federal do Paraná	Curitiba	Paraná	Brazil	80060-900
4	Universidade Federal de São Paulo - UNIFESP - UNICCO	São Paulo		Brazil	04022-000