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OpenTrials
Completed

NCT Number: NCT00978887

Retorna Facial Cream in the Treatment of Facial Wrinkles

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.

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Key information

Conditions

Facial Wrinkles

Age range

20 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

"Commander Manuel Fajardo Rivero" Hospital

Havana, La Habana, 10400, Cuba

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Retorna

Other

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

Placebo

Other

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

Primary outcomes

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

    Time frame: 4 weeks

Secondary outcomes

  1. Presence of adverse effects within the 4 week treatment period

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 17, 2009
Registry last updated
May 18, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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