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CompletedNCT00783666Updated Aug 25, 2009

Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid) - Photo Evaluation

A Phase 3 interventional study of Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix) in Hygiene, sponsored by Sanofi. Completed at 1 site in Brazil. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-08-25.

Sponsored by Sanofi · Phase 3, Interventional, and Supportive care

Phase
Phase 3
Study type
Interventional
Enrollment
26
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • Hygiene
03

In context

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 3
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    1

    Lactic Acid

    Drug: Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)

Interventions

  • DrugLactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)

    Lactic Acid

06

What researchers measure

Primary outcomes

  1. The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale.

    Time frame: Throughout the study

  2. The sensibility will be evaluated according to the skin type.

    Time frame: Throghout the study

07

Study locations

1 site
  • Sanofi-Aventis Administrative Office
    Sao Paulo, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00783666
Lead sponsor
Sanofi
First posted
Nov 2, 2008
Start date
Aug 2008
Primary completion
Sep 2008
Completion
Sep 2008
Last update
Aug 25, 2009

Study contacts

Jaderson Lima
study director · Sanofi
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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