Clinical Trial: Multi-point Intra-mucosal Injections of Cross-linked Hyaluronic Acid (DESIRIAL®) in the Vaginal Vestibule

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Evaluation of the Effect of Multi-point Intra-mucosal Injections of Cross-linked Hyaluronic Acid (DESIRIAL®) in the Vaginal Vestibule: A Prospective, Bicentric, Pilot Study

Brief Summary: The main objective of this study is to measure changes in the thickness of the vaginal lining (epithelium + underlying stroma) between 0 and 8 weeks after injection.

Detailed Summary:

The secondary objectives of this study are to measure changes in the following between 0 and 8 weeks after injection:

A. vaginal flora and Nugent score.

B. vaginal pH.

C. functional evolution via the VHI index by Gloria Bachman (state of the vaginal mucosa), pain / dyspareunia (visual analog scale) and the satisfaction concerning care viay the PGI-I questionnaire (Patient Global Impression and Improvement).

D. Procollagen I and III gene expression (by PCR) and mitotic activity of the mucosa (Ki67 proliferation marker) based on biopsies.


Sponsor: Centre Hospitalier Universitaire de Nīmes

Current Primary Outcome:

  • The thickness of the vaginal mucosa on a histological section [ Time Frame: Day 0 ]
  • The thickness of the vaginal mucosa on a histological section [ Time Frame: Week 8 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Vaginal pH [ Time Frame: Day 0 ]
  • Vaginal pH [ Time Frame: Week 8 ]
  • Vaginal flora (on Pap smear) [ Time Frame: Day 0 ]
  • Vaginal flora (on Pap smear) [ Time Frame: Week 8 ]
  • Nugent score (on Pap smear) [ Time Frame: Day 0 ]
  • Nugent score (on Pap smear) [ Time Frame: Week 8 ]
  • PGI-I (Patient Global Impression and Improvement) Questionnaire [ Time Frame: Week 8 ]
  • The Vaginal Health Index by Gloria Bachman [ Time Frame: Day 0 ]
  • The Vaginal Health Index by Gloria Bachman [ Time Frame: Week 8 ]
  • Pain (dyspareunia) by visual analog scale [ Time Frame: Day 0 ]
  • Pain (dyspareunia) by visual analog scale [ Time Frame: Week 8 ]
  • Measurement of collagen expression (procollagen I and III) [ Time Frame: Day 0 ]
  • Measurement of collagen expression (procollagen I and III) [ Time Frame: Week 8 ]
  • Level of Ki67 proliferation marker [ Time Frame: Day 0 ]
  • Level of Ki67 proliferation marker [ Time Frame: Week 8 ]


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire de Nīmes

Dates:
Date Received: April 6, 2016
Date Started: July 2017
Date Completion: January 2018
Last Updated: September 19, 2016
Last Verified: September 2016