Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid) - Safety.

Hygiene Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00785642
• Other study ID #: LACAC_L_04304
• Status: Completed
• Phase: Phase 3
• First received: November 4, 2008
• Last updated: March 5, 2009
• Start date: August 2008

Study information

• Verified date: March 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 10 Years to 20 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hygiene

Intervention

Drug:
• Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid)

Locations

Country	Name	City	State
Brazil	Sanofi-Aventis Administrative Office	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction.		From the treatment start to the end of the study	No