Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid)- Compatibility
Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT00784160
Collaborator
(none)
53
1
1
2
26
Study Details
Study Description
Brief Summary
The purpose of this study is to demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd PHDETINBACK Tangerine Mix (Lactic Acid).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
53 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd PH_DETINBACK Tangerine Mix.
Study Start Date
:
Jul 1, 2008
Actual Primary Completion Date
:
Sep 1, 2008
Actual Study Completion Date
:
Sep 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 Lactic Acid |
Drug: Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)
Lactic Acid
|
Outcome Measures
Primary Outcome Measures
- The absence of primary and accumulated dermical irritability and dermical sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale. [Throughout the study]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 60 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion criteria:
-
Age between 18 and 60 years old;
-
Phototype Skin I,II, III e IV;
-
Integral skin test in the region;
-
Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion;
Exclusion criteria:
-
Lactation or gestation;
-
Personnel history of atopy;
-
History of sensitivity or irritation for topic products;
-
Active cutaneous disease;
-
Use of new drugs or cosmetics during the study;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sanofi-Aventis Administrative Office | Sao Paulo | Brazil |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Jaderson Lima, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00784160
Other Study ID Numbers:
- LACAC_L_04308
First Posted:
Nov 2, 2008
Last Update Posted:
Aug 25, 2009
Last Verified:
Aug 1, 2009