CClinicalTrials.gg
CompletedNCT00794612Updated Dec 19, 2008

Dermacyd Femina Pocket BR (Lactic Acid)- Acceptability.

A Phase 3 interventional study of Dermacyd Femina Pocket BR (Lactic Acid) in Hygiene, sponsored by Sanofi. Completed at 1 site in Brazil. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-12-19.

Sponsored by Sanofi · Phase 3, Interventional, and Supportive care

Phase
Phase 3
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
Female
01

Study summary

The purpose of this study is to prove the safety of the gynaecological formulation in normal conditions of use.

02

Conditions studied

  • Hygiene
03

In context

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Integral skin test in the region;
  • To use products of the same category;

Exclusion criteria

Exclusion criteria:

  • Lactation or gestation;
  • Use of anti-inflammatory, anti-histaminic or immunosuppressant drugs;
  • Cutaneous disease (local or spread) in the evaluation area;
  • Pathology which may cause immunity depression, such as HIV, diabetes;
  • Endocrine pathology
  • Solar exposure 15 days before evaluation;
  • Treatment until four months before the selection.
  • Allergic or atopic history to cosmetics products

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

05

Study design

Phase
Phase 3
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    1

    Dermacyd Femina Pocket BR (Lactic Acid)

    Drug: Dermacyd Femina Pocket BR (Lactic Acid)

Interventions

  • DrugDermacyd Femina Pocket BR (Lactic Acid)

    Dermacyd Femina Pocket BR (Lactic Acid) during 21 consecutive days

06

What researchers measure

Primary outcomes

  1. Absence of irritation

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

  2. Good acceptability

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

07

Study locations

1 site
  • Sanofi-Aventis Administrative Office
    Sao Paulo, Brazil
08

References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00794612
Lead sponsor
Sanofi
First posted
Nov 20, 2008
Start date
Nov 2008
Primary completion
Nov 2008
Last update
Dec 19, 2008

Study contacts

Jaderson Lima
study director · Sanofi
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.

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