Retorna Facial Cream in the Treatment of Facial Wrinkles

Facial Wrinkles Clinical Trial

Official title:

Efficacy of Retorna Facial Cream Usage in the Treatment of Facial Wrinkles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00978887
• Other study ID #: CAT-0906-CU
• Status: Completed
• Phase: Phase 3
• First received: September 16, 2009
• Last updated: May 17, 2010
• Start date: October 2009
• Est. completion date: May 2010

Study information

• Verified date: May 2010
• Source: Catalysis SL
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cuba: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Facial Wrinkles
• Facies

Intervention

Other:
• Retorna
Dosage commensurate with surface to be treated, Retorna facial cream (Topical use), twice a day, for 4 weeks.
• Placebo
Dosage commensurate with surface to be treated, Placebo facial cream (Topical use), twice a day, for 4 weeks

Locations

Country	Name	City	State
Cuba	"Commander Manuel Fajardo Rivero" Hospital	Havana City	Havana

Sponsors (1)

Lead Sponsor	Collaborator
Catalysis SL

Country where clinical trial is conducted

Cuba, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total correction or improvement of facial wrinkles at the end of treatment (4 weeks)		4 weeks	No
Secondary	Presence of adverse effects within the 4 week treatment period		4 weeks	Yes