NCT00679562

Brief Summary

Primay objective: To evaluate the potential of the products in eliciting adverse skin reaction.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 15, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2008

Completed
Last Updated

February 6, 2009

Status Verified

February 1, 2009

Enrollment Period

1 month

First QC Date

May 15, 2008

Last Update Submit

February 5, 2009

Conditions

Hygiene

Outcome Measures

Primary Outcomes (1)

  • Reaction after patch removal.

    at 15-30 minutes and day 3

Study Arms (2)

1

EXPERIMENTAL
Drug: Lactic Acid

2

PLACEBO COMPARATOR
Other: Distilled water

Interventions

Lactic AcidDRUG

Application of occlusive patches containing test product. For 24 hours and repeat 2 weeks later for participants with no reaction to Lactacyd Radiance

Also known as: Lactacyd Radiance
1
Distilled waterOTHER

Application of patches containing distilled water for 24 hours

2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Test area should have a healthy or normal skin
  • Individuals free of any systemic or dermatological disorder which, in the opinion of the investigative personnel would interfere with the study results or increase the risk of adverse reaction
  • Not currently use of steroid or any medication during the test

You may not qualify if:

  • History of Allergy or Allergic Reaction to:
  • Hey Fever
  • Asthma
  • Poison Ivy
  • Food
  • Cosmetics
  • Soap
  • Detergent
  • Metal
  • Jewelry
  • Lather
  • Fabric
  • Medication
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis Administrative Office

Bangkok, Thailand

Location

MeSH Terms

Interventions

Lactic Acid

Intervention Hierarchy (Ancestors)

LactatesHydroxy AcidsCarboxylic AcidsOrganic Chemicals

Study Officials

  • Taweeporn NATESUMROENG

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 15, 2008

First Posted

May 19, 2008

Study Start

March 1, 2008

Primary Completion

April 1, 2008

Last Updated

February 6, 2009

Record last verified: 2009-02

Locations

TH(1)