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Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid) - Photo Evaluation

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Sanofi

Status and phase

Completed
Phase 3

Conditions

Hygiene

Treatments

Drug: Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00783666
LACAC_L_04309

Details and patient eligibility

About

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

Enrollment

26 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 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

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

26 participants in 1 patient group

1
Experimental group
Description:
Lactic Acid
Treatment:
Drug: Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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