Retorna Facial Cream in the Treatment of Facial Wrinkles

May 17, 2010 updated by: Catalysis SL

Efficacy of Retorna Facial Cream Usage in the Treatment of Facial Wrinkles

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

148

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cuba
    • Havana
      • Havana City, Havana, Cuba, 10400
        • "Commander Manuel Fajardo Rivero" Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
Retorna (facial cream)
Other: Retorna
Dosage commensurate with surface to be treated, Retorna facial cream (Topical use), twice a day, for 4 weeks.
PLACEBO_COMPARATOR: B
Placebo (facial cream)
Other: Placebo
Dosage commensurate with surface to be treated, Placebo facial cream (Topical use), twice a day, for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total correction or improvement of facial wrinkles at the end of treatment (4 weeks)
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Presence of adverse effects within the 4 week treatment period
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catalysis SL

Investigators

  • Principal Investigator: Jose Dominguez Gómez, MD, "Commander Manuel Fajardo Rivero" Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

September 16, 2009

First Submitted That Met QC Criteria

September 16, 2009

First Posted (ESTIMATE)

September 17, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

May 18, 2010

Last Update Submitted That Met QC Criteria

May 17, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAT-0906-CU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Facial Wrinkles

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe