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.

Female Dry Genital Mucosa Clinical Trial

— DERM GYN ACCEP  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03007615
• Other study ID #: Kley Hertz 007
• Status: Not yet recruiting
• Phase: N/A
• First received: December 29, 2016
• Last updated: December 29, 2016
• Start date: January 2017

Study information

• Verified date: December 2016
• Source: Kley Hertz S/A
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 33
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Female Dry Genital Mucosa

Intervention

Other:
• Intimate Lubricant Gel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kley Hertz S/A

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the product's efficiency as a moisturizer through subjective evaluation		30 days	No