Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid) - Photo Evaluation

The purpose of this study is to demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd PHDETINLYN Tangerine Mix (Lactic Acid).

Completed

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Key information

Conditions

Hygiene

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis Administrative Office

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age between 18 and 60 years old;
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 immunossupression 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 photo induced 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;

Treatment and study plan

Lactic Acid (Dermacyd PH_DETINLYN Tangerine Mix)

Drug

Lactic Acid (Dermacyd PH_DETINLYN Tangerine Mix)

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid)

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Nov 3, 2008
Registry last updated: Aug 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed