Dermacyd PH_DETINLYN (Lactic Acid) Sweet Flower - Photo Evaluation.
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ClinicalTrials.gov Identifier: NCT00785590 |
Recruitment Status :
Completed
First Posted : November 5, 2008
Last Update Posted : August 25, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hygiene | Drug: Dermacyd PH_DETINLYN (Lactic Acid) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd PH_DETINLYN (Lactic Acid) Sweet Flower. |
Study Start Date : | August 2008 |
Actual Primary Completion Date : | September 2008 |
Actual Study Completion Date : | September 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Dermacyd PH_DETINLYN (Lactic Acid)
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Drug: Dermacyd PH_DETINLYN (Lactic Acid) |
- The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale [ Time Frame: Throughout the study ]
- The sensibility will be evaluated according to the skin type. [ Time Frame: Throughout the study ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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 gestation
- Use of Antiinflammatory and/or immunosuppression drugs 15 days before the selection;
- Diseases which can cause immunity decrease, such as HIV, diabetes;
- Use of drug photosensitizer;
- History of sensitivity or irritation for topic products;
- Active cutaneous disease which can change the study results;
- History of photodermatosis active;
- Family or personal antecedent of cutaneous photoinduced neoplasias;
- Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and queratoses actinium;
- Intense solar exposure in the study area;
- Use of new drugs or cosmetics during the study
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): NCT00785590
Brazil | |
Sanofi-Aventis Administrative Office | |
Sao Paulo, Brazil |
Study Director: | Jaderson Lima | Sanofi |
Responsible Party: | Medical Affairs Study Director, sanofi-aventis |
ClinicalTrials.gov Identifier: | NCT00785590 History of Changes |
Other Study ID Numbers: |
LACAC_L_04300 |
First Posted: | November 5, 2008 Key Record Dates |
Last Update Posted: | August 25, 2009 |
Last Verified: | August 2009 |