Dermacyd Silver Floral (Lactic Acid) - Photo Evaluation

NCT00932984 | Completed Phase 3

• 1 other identifier: LACAC_L_04840
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: To demonstrate the absence of photoirritation and potential photosensitization of the product Dermacyd Silver Floral.

Conditions

Hygiene

Outcome Measures

Primary Outcomes (1)

• 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.

  From the treatment start to the end of the study (treatment period 5 weeks)

Study Arms (1)

Dermacyd Silver Floral (Lactic Acid)

EXPERIMENTAL

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)

Interventions

LACTIC ACID(ND) DRUG

Dermacyd Silver Floral (Lactic Acid) sample will be applied like a curative during 5 weeks (treatment period).

Dermacyd Silver Floral (Lactic Acid)

Eligibility Criteria

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

You may qualify if:

• 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 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

São Paulo, Brazil

Location

Study Officials

• Jaderson Lima

  Sanofi

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 3, 2009
• First Posted: July 7, 2009
• Study Start: June 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: September 14, 2010

Record last verified: 2010-09

Locations

BR (1)