Retorna Facial Cream in the Treatment of Facial Wrinkles | NCT00978887

Studies
Retorna Facial Cream in the Treatment of Facial Wrinkles

NCT00978887

Sponsor

Catalysis SL

Status

Completed

Last Update Posted

May 18, 2010Estimated

Enrollment

148Estimated

Phase

Phase 3

Conditions

Facial Wrinkles

Interventions

Retorna
Placebo

Countries

Cuba

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

May 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Sep 16, 2009

First Submission Date that Met QC Criteria

Sep 16, 2009

First Posted Date

Sep 17, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2010

Last Update Posted Date

May 18, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

148Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Retorna (facial cream)	Other: Retorna
B	Placebo Comparator	Placebo (facial cream)	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Retorna	Other	Dosage commensurate with surface to be treated, Retorna facial cream (Topical use), twice a day, for 4 weeks.	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total correction or improvement of facial wrinkles at the end of treatment (4 weeks)		4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Presence of adverse effects within the 4 week treatment period		4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jose Dominguez Gómez, MD	"Commander Manuel Fajardo Rivero" Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
"Commander Manuel Fajardo Rivero" Hospital		Havana	La Habana	10400	Cuba