Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid) - Safety.

NCT00783939 | Completed Phase 3

• 1 other identifier: LACAC_L_04307
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to prove the safety in normal conditions of useof the product Dermacyd PH\_DETINBACK Tangerine Mix (Lactic Acid).

Conditions

Hygiene

Outcome Measures

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.

  From the treatment start to the end of the study

Study Arms (1)

1

EXPERIMENTAL

Lactic Acid (Dermacyd PH\_DETINBACK Tangerine Mix)

Drug: Lactic Acid

Interventions

Lactic Acid DRUG

Lactic Acid (Dermacyd PH\_DETINBACK Tangerine Mix)

1

Eligibility Criteria

• Age: 10 Years - 20 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 10 and 20 years old;
• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

São Paulo, Brazil

Location

MeSH Terms

Interventions

Lactic Acid

Intervention Hierarchy (Ancestors)

Lactates; Hydroxy Acids; Carboxylic Acids; Organic Chemicals

Study Officials

• Jaderson Lima

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 31, 2008
• First Posted: November 3, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2008
• Last Updated: March 6, 2009

Record last verified: 2009-03

Locations

BR (1)