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Trial record 2 of 6 for:    lactic acid | Citrus reticulata

Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid) - Safety.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00785642
Recruitment Status : Completed
First Posted : November 5, 2008
Last Update Posted : March 6, 2009
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Brief Summary:
To prove the safety of the gynaecological formulation in normal conditions of use.

Condition or disease Intervention/treatment Phase
Hygiene Drug: Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Safety Dermatological Evaluation: Genital Mucous Irritation - Product Tested: Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid).
Study Start Date : August 2008
Actual Primary Completion Date : September 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid)
Drug: Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid)

Primary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00785642

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Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Sponsors and Collaborators
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Study Director: Jaderson Lima Sanofi

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Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00785642     History of Changes
Other Study ID Numbers: LACAC_L_04304
First Posted: November 5, 2008    Key Record Dates
Last Update Posted: March 6, 2009
Last Verified: March 2009