Lactacyd Radiance (Lactic Acid) Prophetic Patch Test

Sanofi

Status and phase: Completed; Phase 2

Conditions: Hygiene

Treatments: Drug: Lactic Acid; Other: Distilled water

Study type: Interventional

Funder types: Industry

Identifiers

NCT00679562

LACAC_L_03648

Details and patient eligibility

About

Primay objective:

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

Enrollment: 200 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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200 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Lactic Acid

2

Placebo Comparator group

Treatment:

Other: Distilled water