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Retorna Facial Cream in the Treatment of Facial Wrinkles

This study has been completed.
Sponsor:
Information provided by:
Catalysis SL
ClinicalTrials.gov Identifier:
NCT00978887
First received: September 16, 2009
Last updated: May 17, 2010
Last verified: May 2010
  Purpose

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 Intervention Phase
Facial Wrinkles
Other: Retorna
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Retorna Facial Cream Usage in the Treatment of Facial Wrinkles

Further study details as provided by Catalysis SL:

Primary Outcome Measures:
  • Total correction or improvement of facial wrinkles at the end of treatment (4 weeks) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Presence of adverse effects within the 4 week treatment period [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 148
Study Start Date: October 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: September 16, 2009
Last Updated: May 17, 2010
Health Authority: Cuba: Institutional Review Board

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

Additional relevant MeSH terms:
Facies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014