Retorna Facial Cream in the Treatment of Facial Wrinkles
This study has been completed.
Sponsor:
Catalysis SL
Information provided by:
Catalysis SL
ClinicalTrials.gov Identifier:
NCT00978887
First received: September 16, 2009
Last updated: May 17, 2010
Last verified: May 2010
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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
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 June 17, 2013