Facial Wrinkles
Conditions
Keywords
Facial cream, natural product, facial wrinkles
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.
Interventions
OTHERRetorna
Dosage commensurate with surface to be treated, Retorna facial cream (Topical use), twice a day, for 4 weeks.
OTHERPlacebo
Dosage commensurate with surface to be treated, Placebo facial cream (Topical use), twice a day, for 4 weeks
Sponsors
Catalysis SL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 60 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total correction or improvement of facial wrinkles at the end of treatment (4 weeks) | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Presence of adverse effects within the 4 week treatment period | 4 weeks |
Countries
Cuba
Outcome results
None listed