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Dermacyd Breeze (Lactic Acid) Pocket BR - Photo Evaluation

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Sanofi

Status and phase

Completed
Phase 3

Conditions

Hygiene

Treatments

Drug: Lactic Acid

Study type

Interventional

Funder types

Industry

Identifiers

NCT00784069
LACAC_L_04367

Details and patient eligibility

About

To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd Breeze (Lactic Acid) Pocket BR.

Enrollment

27 patients

Sex

Female

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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 immunosuppression 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

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

Single Group Assignment

Masking

None (Open label)

27 participants in 1 patient group

1
Experimental group
Description:
Lactic Acid (Dermacyd Breeze)
Treatment:
Drug: Lactic Acid

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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