Dermacyd Silver Frutal (Lactic Acid) - Compatibility.

Study for Dermatological Evaluation of Topic Compatibility Primary and Accumulated Dermical Irritability and Dermical Sensitivity for the Product Dermacyd Silver Frutal (Lactic Acid).

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00933946

Enrollment

Registered

2009-07-07

Start date

2009-06-30

Completion date

2009-07-31

Last updated

2010-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hygiene

Brief summary

Primary Objective: To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Silver Frutal.

Interventions

DRUGLACTIC ACID(ND)

Dermacyd Silver Frutal (Lactic Acid) sample will be applied like a curative for 21 consecutive days.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* Phototype Skin I,II, III e IV * 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 pregnancy * Use of Antiinflammatory 30 days and/or immunossupression drugs for until 3 months before volunteers selection * Diseases which can cause immunosuppresion, such as diabetes, HIV * Personal history of atopy * History of sensitivity or irritation for topic products * Cutaneous active disease (local and/or general) which can modify the study results * Use of new drugs and/or cosmetics during the study * Cutaneous reaction * Previous participation in studies using the same product in test * Volunteer which has immunodeficiency congenital or acquired * Relevant history or confirmation of alcohol or other drugs abuse * Intolerance detected or suspected for some component of the sample tested * Medecin or sponsor employees or their close family. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Design outcomes

Primary

Measure	Time frame
Evaluation of the absence of primary and accumulated dermical irritability and dermical sensitivity by using International Contact Dermatitis Research Group (ICDRG) scale.	from the treatment start to the end of the study (treatment period 6 weeks)

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026