Dermacyd Silver Floral (Lactic Acid) - Photo Evaluation
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00932984
First received: July 3, 2009
Last updated: September 13, 2010
Last verified: September 2010
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Purpose
Primary Objective:
To demonstrate the absence of photoirritation and potential photosensitization of the product Dermacyd Silver Floral.
| Condition | Intervention | Phase |
|---|---|---|
|
Hygiene |
Drug: LACTIC ACID(ND) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Silver Floral (Lactic Acid). |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Measure of the photo irritation test and the photosensitivity by using UVA irradiation and evaluation according International Contact Dermatitis Research Group (ICDRG) scale. Evaluation of the sensibility according to the skin type. [ Time Frame: From the treatment start to the end of the study (treatment period 5 weeks) ] [ Designated as safety issue: No ]
| Enrollment: | 27 |
| Study Start Date: | June 2009 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Dermacyd Silver Floral (Lactic Acid)
Dermacyd Silver Floral (Lactic Acid) sample will be applied like a curative. Physiologic solution and mineral oil will be also used as a control sample.
|
Drug: LACTIC ACID(ND)
Dermacyd Silver Floral (Lactic Acid) sample will be applied like a curative during 5 weeks (treatment period).
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion criteria:
- Phototype Skin II and III 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 pregnancy
- Use of Antiinflammatory 30 days and/or immunossupression drugs for until 3 months before volunteers selection
- Disease which can cause immunosuppresion, such as diabetes, HIV
- Concomitant use of photosensitivity drugs
- History of sensitivity or photosensitivity withr topic products
- Cutaneous active disease which can modify the study results
- History or activity of photodermatosis
- Personal or family antecedents of cutaneous neoplasia photo induced
- Presence of injury precursor of cutaneous neoplasia, such as melanociticos nevus and actinic keratosis
- Intense exposure solar in the test region
- Use of new drugs and/or cosmetics during the study
- Previous participation in studies using the same product in test
- Relevant history or confirmation of alcohol or other drugs abuse
- Intolerance detected or suspected for some component of the sample tested
- Medecin or sponsor employees or their close family.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Medical Affairs Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00932984 History of Changes |
| Other Study ID Numbers: | LACAC_L_04840 |
| Study First Received: | July 3, 2009 |
| Last Updated: | September 13, 2010 |
| Health Authority: | Brazil: National Health Surveillance Agency |
ClinicalTrials.gov processed this record on May 19, 2013