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CompletedNCT00668629Updated Jan 29, 2009

Dermacyd Tina Gel Sweet Flower - Photo Evaluation

A Phase 3 interventional study of Lactic acid (Dermacid) in Healthy, 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 2009-01-29.

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

Phase
Phase 3
Study type
Interventional
Enrollment
25
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
Female
01

Study summary

The purpose of this study is to prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Tina Gel Sweet Flower.

02

Conditions studied

  • Healthy

Keywords

  • 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

  • Phototype Skin II and III
  • Integral skin test in the region

Exclusion criteria

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 or photodermatosis active
  • Family or personal antecedent of cutaneous photoinduced neoplasias
  • Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses 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.

05

Study design

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

Interventions

  • DrugLactic acid (Dermacid)
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. The sensibility will be evaluated according to the skin type.

    Time frame: 5 weeks

07

Study locations

1 site
  • Sanofi-aventis administrative office
    São Paulo, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00668629
Lead sponsor
Sanofi
First posted
Apr 29, 2008
Start date
Nov 2007
Primary completion
Jan 2008
Last update
Jan 29, 2009

Study contacts

Jaderson Lima
study director · Sanofi-aventis administrative office Brazil

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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