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Dermal and Gynecological Acceptability (Irritability and Sensitization in the Genital Mucosa) of an Investigational Product and Evaluation of Moisture Efficacy by TEWL and Perceived Efficacy. (DERM GYN ACCEP)

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ClinicalTrials.gov Identifier: NCT03007615
Recruitment Status : Not yet recruiting
First Posted : January 2, 2017
Last Update Posted : January 2, 2017
Sponsor:
Information provided by (Responsible Party):
Kley Hertz S/A

Brief Summary:
To evaluate the safety of an investigational product through the verification of signs of irritability and sensitization of the genital mucosa, as well as the instrumental moisturizing efficacy by TEWL and barrier integrity analysis, in addition to the efficacy perceived by the volunteers.

Condition or disease Intervention/treatment Phase
Female Dry Genital Mucosa Other: Intimate Lubricant Gel Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Official Title: Dermal and Gynecological Acceptability (Irritability and Sensitization in the Genital Mucosa) of an Investigational Product and Evaluation of Moisture Efficacy by TEWL and Perceived Efficacy.
Study Start Date : January 2017
Estimated Primary Completion Date : February 2017

Arm Intervention/treatment
Experimental: Experimental group Other: Intimate Lubricant Gel



Primary Outcome Measures :
  1. Evaluation of the product's efficiency as a moisturizer through subjective evaluation [ Time Frame: 30 days ]


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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy female sex with active sex life;
  • Age group: between 45 and 65 years old;
  • Menopause for at least six months;
  • Whole skin in the region of product analysis;
  • No history of reaction to products of the same category
  • Understanding, agreement and signature of the Term of Free and Informed Consent.

Exclusion Criteria:

  • Gestation or risk of gestation;
  • Use of anti-inflammatory / immunosuppressive drugs (in the last 30 days and during the study);
  • Active cutaneous pathologies (local and / or disseminated) in the evaluation area;
  • Pathologies that cause suppression of immunity, such as diabetes, HIV, etc.;
  • Endocrine pathologies such as thyroid disorders, ovarian or adrenal gland disorders;
  • Any infection in the region of analysis of the product diagnosed at the time of inclusion;
  • Other conditions considered by the investigating physician as reasonable for disqualification of the individual from the study participation.

Responsible Party: Kley Hertz S/A
ClinicalTrials.gov Identifier: NCT03007615     History of Changes
Other Study ID Numbers: Kley Hertz 007
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: January 2, 2017
Last Verified: December 2016