Retorna Facial Cream in the Treatment of Facial Wrinkles

Catalysis SL148 enrolled

Overview

The purpose of the study is to assess the efficacy of Retorna facial cream usage in the reduction or total correction of facial wrinkles. The duration of this double-blind placebo controlled phase 3 clinical trial will be 4 weeks. The estimated number of women to be recruited and randomized for the study is 148. Occurrence of adverse effects will also be evaluated.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

148

Conditions

Facial Wrinkles

Interventions

RetornaOTHER

Dosage commensurate with surface to be treated, Retorna facial cream (Topical use), twice a day, for 4 weeks.

PlaceboOTHER

Dosage commensurate with surface to be treated, Placebo facial cream (Topical use), twice a day, for 4 weeks

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Facial wrinkles * Signed informed consent * Given verbal agreement on solar exposure prevention within hours of intense solar radiation (10 am - 4 pm) by the usage of physical protection methods such as umbrellas, caps and hats. Exclusion Criteria: * Pregnancy * Breast-feeding * Use of steroids within 6 months. * Patients under other experimental treatment * Decompensated concomitant diseases * Malignant neoplastic conditions. * Alcoholism * Handicap and/or psychiatric condition preventing treatment accomplishment.

Locations (1)

"Commander Manuel Fajardo Rivero" Hospital

Havana, La Habana, Cuba

Outcomes

Primary Outcomes

Total correction or improvement of facial wrinkles at the end of treatment (4 weeks)

Time frame: 4 weeks

Secondary Outcomes

Presence of adverse effects within the 4 week treatment period

Time frame: 4 weeks

Data from ClinicalTrials.gov

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