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Retorna Facial Cream in the Treatment of Facial Wrinkles

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00978887
First Posted: September 17, 2009
Last Update Posted: May 18, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Catalysis SL
September 16, 2009
September 17, 2009
May 18, 2010
October 2009
May 2010   (Final data collection date for primary outcome measure)
Total correction or improvement of facial wrinkles at the end of treatment (4 weeks) [ Time Frame: 4 weeks ]
Same as current
Complete list of historical versions of study NCT00978887 on ClinicalTrials.gov Archive Site
Presence of adverse effects within the 4 week treatment period [ Time Frame: 4 weeks ]
Same as current
Not Provided
Not Provided
 
Retorna Facial Cream in the Treatment of Facial Wrinkles
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Facial Wrinkles
  • Other: Retorna
    Dosage commensurate with surface to be treated, Retorna facial cream (Topical use), twice a day, for 4 weeks.
  • Other: Placebo
    Dosage commensurate with surface to be treated, Placebo facial cream (Topical use), twice a day, for 4 weeks
  • Experimental: A
    Retorna (facial cream)
    Intervention: Other: Retorna
  • Placebo Comparator: B
    Placebo (facial cream)
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
148
May 2010
May 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
20 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Cuba
 
 
NCT00978887
CAT-0906-CU
Yes
Not Provided
Not Provided
Alfredo Abreu Daniel PhD, "Commander Manuel Fajardo Rivero" Hospital
Catalysis SL
Not Provided
Principal Investigator: Jose Dominguez Gómez, MD "Commander Manuel Fajardo Rivero" Hospital
Catalysis SL
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP