NCT00978887CompletedPhase 3
Efficacy of Retorna Facial Cream Usage in the Treatment of Facial Wrinkles
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Catalysis SL
- Enrollment
- 148
- Locations
- 2
- Primary Endpoint
- Total correction or improvement of facial wrinkles at the end of treatment (4 weeks)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Total correction or improvement of facial wrinkles at the end of treatment (4 weeks)
Time Frame: 4 weeks
Secondary Outcomes
- Presence of adverse effects within the 4 week treatment period(4 weeks)
Investigators
Study Sites (2)
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