Retorna Facial Cream in the Treatment of Facial Wrinkles
Phase 3
Completed
- Conditions
- Facial Wrinkles
- Interventions
- Other: RetornaOther: Placebo
- Registration Number
- NCT00978887
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 148
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Retorna Retorna (facial cream) B Placebo Placebo (facial cream)
- Primary Outcome Measures
Name Time Method Total correction or improvement of facial wrinkles at the end of treatment (4 weeks) 4 weeks
- Secondary Outcome Measures
Name Time Method Presence of adverse effects within the 4 week treatment period 4 weeks
Trial Locations
- Locations (1)
"Commander Manuel Fajardo Rivero" Hospital
🇨🇺Havana City, Havana, Cuba