NCT00978887

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2009

Completed
14 days until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

May 18, 2010

Status Verified

May 1, 2010

Enrollment Period

7 months

First QC Date

September 16, 2009

Last Update Submit

May 17, 2010

Conditions

Facial Wrinkles

Keywords

Facial creamnatural productfacial wrinkles

Outcome Measures

Primary Outcomes (1)

  • Total correction or improvement of facial wrinkles at the end of treatment (4 weeks)

    4 weeks

Secondary Outcomes (1)

  • Presence of adverse effects within the 4 week treatment period

    4 weeks

Study Arms (2)

A

EXPERIMENTAL

Retorna (facial cream)

Other: Retorna

B

PLACEBO COMPARATOR

Placebo (facial cream)

Other: Placebo

Interventions

RetornaOTHER

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

A
PlaceboOTHER

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

B

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Commander Manuel Fajardo Rivero" Hospital

Havana, La Habana, 10400, Cuba

Location

Study Officials

  • Jose Dominguez Gómez, MD

    "Commander Manuel Fajardo Rivero" Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 16, 2009

First Posted

September 17, 2009

Study Start

October 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

May 18, 2010

Record last verified: 2010-05

Locations

CU(1)