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OpenTrials
Completed

NCT Number: NCT00785642

Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid) - Safety.

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

Completed

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Key information

Conditions

Hygiene

Age range

10 year–20 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.

Inclusion criteria

  • Integral skin test in the region;
  • Use of cosmetic product of the same category;
  • Willingness in following the study procedures and to be present in the clinic at the days and scheduled time;

Exclusion criteria

  • Lactation or gestational risk or gestation;
  • Use of Anti-inflammatory, immunosuppression or antihistaminic drugs;
  • Atopic antecedent or allergic to cosmetic product;
  • Active cutaneous disease in the evaluation area;
  • Diseases which cause immunology decrease, such as diabetes and HIV;
  • Endocrinal pathologies;
  • Intense solar exposure 15 days before the evaluation;
  • Treatment until four months before the selection

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

Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid)

Drug

Primary outcomes

  1. The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction.

    Time frame: From the treatment start to the end of the study

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Safety Dermatological Evaluation: Genital Mucous Irritation - Product Tested: Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid).

Important dates

Study start
2008
Primary completion
2008
First posted
Nov 5, 2008
Registry last updated
Mar 6, 2009

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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