Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Tina Gel Sweet Flower
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ClinicalTrials.gov Identifier: NCT00663273 |
Recruitment Status :
Completed
First Posted : April 22, 2008
Last Update Posted : January 8, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hygiene | Drug: Lactic acid (Dermacid) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Tina Gel Sweet Flower |
Study Start Date : | December 2007 |
Actual Primary Completion Date : | January 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Lactic acid in small quantity during 21 days.
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Drug: Lactic acid (Dermacid)
Liquid soup to be applied in the external genital area, in a small quantity, with abundantly rinse after use, during 21 days. |
- Adverse events and their intensity and their association with the treatment. [ Time Frame: 21 days ]

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Ages Eligible for Study: | 10 Years to 20 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Integral skin test in the region;
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00663273
Brazil | |
Sanofi-aventis | |
São Paulo, Brazil |
Study Director: | Jaderson Lima | Sanofi-aventis administrative office Brazil |
Responsible Party: | GMA-CO/Medical Director, sanofi-aventis administrative office France |
ClinicalTrials.gov Identifier: | NCT00663273 History of Changes |
Other Study ID Numbers: |
LACAC_L_03732 |
First Posted: | April 22, 2008 Key Record Dates |
Last Update Posted: | January 8, 2009 |
Last Verified: | January 2009 |
Additional relevant MeSH terms:
Dermatologic Agents |