Retorna Facial Cream in the Treatment of Facial Wrinkles

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Facial Wrinkles

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A

Retorna (facial cream)

Group Type EXPERIMENTAL

Retorna

Intervention Type OTHER

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

B

Placebo (facial cream)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Retorna

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

Intervention Type OTHER

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No