Dermacyd Tina Gel Sweet Flower - Photo Evaluation

Healthy Clinical Trial

Official title:

Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Tina Gel Sweet Flower.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00668629
• Other study ID #: LACAC_L_03734
• Status: Completed
• Phase: Phase 3
• First received: April 23, 2008
• Last updated: January 27, 2009
• Start date: November 2007

Study information

• Verified date: January 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Tina Gel Sweet Flower.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Phototype Skin II and III

• Integral skin test in the region

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 or photodermatosis active

• Family or personal antecedent of cutaneous photoinduced neoplasias

• Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Lactic acid (Dermacid)

Locations

Country	Name	City	State
Brazil	Sanofi-aventis administrative office	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale. The sensibility will be evaluated according to the skin type.		5 weeks	Yes