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Retorna Facial Cream in the Treatment of Facial Wrinkles

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ClinicalTrials.gov Identifier: NCT00978887
Recruitment Status : Completed
First Posted : September 17, 2009
Last Update Posted : May 18, 2010
Sponsor:
Information provided by:
Catalysis SL

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Facial Wrinkles Other: Retorna Other: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Retorna Facial Cream Usage in the Treatment of Facial Wrinkles
Study Start Date : October 2009
Primary Completion Date : May 2010
Study Completion Date : May 2010

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



Primary Outcome Measures :
  1. Total correction or improvement of facial wrinkles at the end of treatment (4 weeks) [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Presence of adverse effects within the 4 week treatment period [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00978887


Locations
Cuba
"Commander Manuel Fajardo Rivero" Hospital
Havana City, Havana, Cuba, 10400
Sponsors and Collaborators
Catalysis SL
Investigators
Principal Investigator: Jose Dominguez Gómez, MD "Commander Manuel Fajardo Rivero" Hospital

Responsible Party: Alfredo Abreu Daniel PhD, "Commander Manuel Fajardo Rivero" Hospital
ClinicalTrials.gov Identifier: NCT00978887     History of Changes
Other Study ID Numbers: CAT-0906-CU
First Posted: September 17, 2009    Key Record Dates
Last Update Posted: May 18, 2010
Last Verified: May 2010

Keywords provided by Catalysis SL:
Facial cream
natural product
facial wrinkles

Additional relevant MeSH terms:
Facies
Disease Attributes
Pathologic Processes