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Clinical Trials/NCT00933413
NCT00933413CompletedPhase 3

Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynecological Follow-up (Dermacyd Silver Frutal (Lactic Acid)).

Sanofi1 site in 1 country30 target enrollmentStarted: June 2009Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Sanofi
Enrollment
30
Locations
1
Primary Endpoint
Evaluation of the absence of irritation and the good acceptability by using one specific scale which describes the intensity of the reaction.

Study Overview

Brief Summary

Primary Objective:

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

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Dermacyd Silver Frutal (Lactic Acid)

Experimental

Application of Lactic acid during 21 consecutive days

Intervention: LACTIC ACID(ND) (Drug)

Outcomes

Primary Outcomes

Evaluation of the absence of irritation and the good acceptability by using one specific scale which describes the intensity of the reaction.

Time Frame: From the treatment start to the end of the study (treatment period 21 consecutive days)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Sanofi
Sponsor Class
Industry

Study Sites (1)

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