Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid) - Photo Evaluation

NCT00783666 | Completed Phase 3

• 1 other identifier: LACAC_L_04309
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hygiene

Outcome Measures

Primary Outcomes (2)

• The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale.

  Throughout the study

• The sensibility will be evaluated according to the skin type.

  Throghout the study

Study Arms (1)

1

EXPERIMENTAL

Lactic Acid

Drug: Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)

Interventions

Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix) DRUG

Lactic Acid

1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

São Paulo, Brazil

Location

MeSH Terms

Interventions

Lactic Acid

Intervention Hierarchy (Ancestors)

Lactates; Hydroxy Acids; Carboxylic Acids; Organic Chemicals

Study Officials

• Jaderson Lima

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 31, 2008
• First Posted: November 3, 2008
• Study Start: August 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: August 25, 2009

Record last verified: 2009-08

Locations

BR (1)