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.

NCT03007615 | Unknown

• 1 other identifier: Kley Hertz 007
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/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.

Conditions

Female Dry Genital Mucosa

Outcome Measures

Primary Outcomes (1)

• Evaluation of the product's efficiency as a moisturizer through subjective evaluation

  30 days

Study Arms (1)

Experimental group

EXPERIMENTAL

Other: Intimate Lubricant Gel

Interventions

Intimate Lubricant Gel OTHER

Experimental group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Other conditions considered by the investigating physician as reasonable for disqualification of the individual from the study participation.

Sponsors & Collaborators

• Kley Hertz S/A: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2016
• First Posted: January 2, 2017
• Study Start: January 1, 2017
• Primary Completion: February 1, 2017
• Last Updated: January 2, 2017

Record last verified: 2016-12