NCT00933413CompletedPhase 3
Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynecological Follow-up (Dermacyd Silver Frutal (Lactic Acid)).
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
Study Sites (1)
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