Efficiency And Safety Of Association Arbutin, Triamcinolone And Tretinoin In Treatment Of Melasma

NCT00717652 | Suspended Phase 2

• 1 other identifier: ATTGLE0508
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is evaluating the clinical activity of the association (tretinoin + arbutin + triamcinolone) in the treatment of epidermal melasma.

Conditions

Melasma

Outcome Measures

Primary Outcomes (1)

• evaluating the clinical activity of the association (tretinoin + arbutin + triamcinolone)in the treatment of epidermal melasma.

  arbutin triamcinolone tretinoin

Study Arms (2)

1

EXPERIMENTAL

arbutin, tretinoin, triamcinolone

Drug: arbutin, tretinoin, triamcinolone

2

ACTIVE COMPARATOR

Triluma

Drug: Triluma

Interventions

arbutin, tretinoin, triamcinolone DRUG

arbutin, tretinoin, triamcinolone

1

Triluma DRUG

Hydroquinone, Fluoncinolone, Tretinoin

2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women adults aged more than 18 years;
• Patients suffering from melasma Epidermal the face of mild and moderate;
• Patients who have not done any treatment for melasma in the 3 months preceding the study;
• Patients with good mental and physical health;
• Patients who agree with the purposes of the study and sign the TCLE.

You may not qualify if:

• Patients with skin diseases other than melasma, which interfere in clinical evaluation as hemangiomas and queloides;
• Patients with melasma skin or mixed;
• Patients with sensitivity to agents hipopigmentantes;
• Patients with sensitivity to fotoprotetores;
• Patients who are pregnant or breastfeeding;
• Patients who, at the discretion doctor, are not able to participate in the study;
• Patients who have carried out any treatment for melasma in the 3 months preceding the study
• Patients who do not agree with the terms described in the Statement of Informed Consent

Sponsors & Collaborators

• Azidus Brasil: lead

Study Sites (1)

Lal Clinica Pesquisa E Desenvolvimento Ltda

Valinhos, S, 13270000, Brazil

Location

MeSH Terms

Conditions

Melanosis

Interventions

Arbutin; Tretinoin; Triamcinolone

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Glucosides; Glycosides; Carbohydrates; Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Dr. Alexandre Frederico

Study Record Dates

• First Submitted: July 15, 2008
• First Posted: July 17, 2008
• Study Start: July 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: November 3, 2022

Record last verified: 2022-11

Locations

BR (1)