NCT00663390

CompletedPhase 3

Safety Dermatological Evaluation: Acceptability With Gynecol...

Sanofi Source

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Other study identifiers

Sponsor study identifier

LACAC_L_03743

Study Type

interventional

Actual enrollment (reported)

30

Locations

1 country

Sites

1

Timeline

Study Start

December 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

January 2008

Actual (reported)

Study Completion

Not reported

Date not reported

Brief Summary

The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Delicata Pocket.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 30 participants
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
December 2007
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
January 2008
Actual (reported)
First Submitted
April 18, 2008
Actual (reported)
First Posted
April 22, 2008
Actual (reported)

Last Updated: January 29, 2009
Status Verified: January 2009
Last Update Submitted: January 28, 2009

Conditions

Hygiene

Outcome Measures

Primary Outcomes (1)

Adverse events and their intensity and their association with the treatment.
21 days

Study Arms (1)

I

EXPERIMENTAL

Drug: Lactic acid (Dermacid)

Interventions

Lactic acid (Dermacid)Drug

Liquid soup to be applied in the external genital area, in a small quantity, with abundantly rinse after use, during 21 days.

I

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 60 Years

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Integral skin test in the region;

You may not qualify if:

Sponsors & Collaborators

Sanofi
Industrylead

Study Sites (1)

Sanofi-aventis

São Paulo, São Paulo, Brazil

MeSH Terms

Interventions

Lactic Acid

Intervention Hierarchy (Ancestors)

LactatesHydroxy AcidsCarboxylic AcidsOrganic Chemicals

Study Officials

Jaderson Lima
Sanofi-aventis administrative office Brazil
STUDY DIRECTOR

Enrollment

30 participants (actual enrollment reported by the registry).

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

April 18, 2008

First Posted

April 22, 2008

Study Start

December 2007

Date type not reported

This date has not been verified as actual or estimated.

NCT01158365

Dermacyd in Odor Reducing.

Phase 3Completed

NCT00705276

Dermacyd Femina Delicata (Lactic Acid)- Photo Dermatological Evaluation of the Irritation and Sensitivity Potential

Phase 3Completed

NCT00370162

Acceptability Dermacyd Delicata - New Fragrance - Lactoserum - Hygiene

Phase 3Completed

NCT00380991

Topic Compatibility Dermacyd Delicata - New Fragrance - Lactoserum - Hygiene

Phase 3Completed

NCT00793026

Dermacyd Breeze Pocket BR (Lactic Acid) - Acceptability

Phase 3Completed

NCT00794612

Dermacyd Femina Pocket BR (Lactic Acid)- Acceptability.

Phase 3Completed

Lactation or gestational risk or gestation;

Use of Anti-inflammatory or immunosuppression drugs 1 month before the study;

Topical medication use at the region to be treated;

Cutaneous disease or active gynecological disease which may interfere in study results;

Personal history of allergic disease at the area to be treated;

Allergic or atopic history;

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

Contact the study team to confirm eligibility.

Primary Completion

January 2008

Actual (reported)

Last Updated

January 29, 2009

Record last verified: 2009-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00663390
Data provider: ClinicalTrials.gov
Source updated: 2009-01-29
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:33:57 UTC

Locations

BR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

I

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations