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OpenTrials
Completed

NCT Number: NCT00932945

Dermacyd PH_DESILSTY_FR (Lactic Acid) - Acceptability - Stay on Frutal

Primary Objective:

To prove the safety of the gynecological formulation in normal conditions of use.

Completed

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Key information

Conditions

Hygiene

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis Administrative Office

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: Yes

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

Exclusion criteria

  • Integral vaginal mucosa in the product analysis region
  • Use the same category of cosmetics products
  • Willingness in following the study procedures and to be present in the clinic at the days and scheduled time

Exclusion criteria

  • Use of Anti-inflammatory, immunossupression or antihistaminics drugs
  • Allergic or atopic history to cosmetics products
  • Cutaneous active disease (local and/or general) in the evaluated area
  • Disease which can cause immunosuppresion, such as diabetes, HIV
  • Endocrinology pathology such as thyroid gland, ovary and adrenal gland
  • Intensive solar exposure until 15 days before evaluation
  • Gynecological treatment until four weeks before the study
  • Other reason considered by the investigator as a reason for not being included.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Treatment and study plan

LACTIC ACID(ND)

Drug

Treatment duration: 21 consecutive days

Primary outcomes

  1. Evaluation of the absence of irritation and the good acceptability by using one specific scale which describes the intensity of the reaction.

    Time frame: From the treatment start up to the end of the study (treatment period 21 days)

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynaecological Follow up - Dermacyd PH_DESILSTY_FR (Lactic Acid).

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 7, 2009
Registry last updated
Sep 14, 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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