The aim of this study is primarily to investigate the performance of Celegyn®, a hyaluronic acid-based vaginal cream (CE marked 0546 medical device), enriched with plant-based ingredients, in comparison with placebo, in promoting vaginal health in adult woman reporting symptoms of vulvovaginal atrophy - VVA (or atrophic vulvovaginitis)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
96
Medical device Celegyn® presents itself as a cream.
IP placebo presents itself as a cream.
Spedali Civili di Brescia
Brescia, Italy
NOT_YET_RECRUITINGIstituto Europeo di Oncologia
Milan, Italy
RECRUITINGFondazione IRCCS Policlinico San Matteo
Pavia, Italy
RECRUITINGAssessment of Vaginal Health Index (VHI)
comparison between groups, mean change from Day 0 to Day 21
Time frame: from Day 0 to Day 21
Assessment of vulvar signs of VVA assessed by means of vulvoscopy
comparison between groups, mean change from Day 0 to Day 21
Time frame: from Day 0 to Day 21
Assessment of vulvar signs of VVA (vaginal secretions, vaginal epithelial integrity, vaginal epithelial surface thickness and vaginal colour, categorized as none, mild, moderate, or severe corresponding to a score of 0, 1, 2 or 3, respectively)
comparison between groups, mean change from Day 0 to Day 21
Time frame: from Day 0 to Day 21
Assessment of visible skin signs of irritation such as redness, dryness, scaling, peeling, bumps, hives, categorized as none, mild, moderate, or severe corresponding to a score of 0, 1, 2 or 3, respectively
comparison between groups, mean change from Day 0 to Day 21
Time frame: from Day 0 to Day 21
Assessment done by Investigator of overall improvement by means of Global Assessment of Improvement (GAI - according to a 7-grade scoring system, 0-6)
comparison between groups, at Day 21
Time frame: at Day 21
Assessment of subjective vaginal symptoms related to VVA and irritation (dryness, dyspareunia, burning, itching, stinging) by means of 100 mm Visual Analogue Scales
comparison between groups, mean change from Day 0 to Day 21
Time frame: from Day 0 to 21
Assessment of global severity score for symptoms of VVA
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comparison between groups, mean change from Day 0 to Day 21
Time frame: from Day 0 to Day 21
Assessment of dyspareunia by means of the Marinoff Dyspareunia Scale
comparison between groups, mean change from Day 0 to Day 21
Time frame: from Day 0 to Day 21
Assessment of pain through the short form of McGill Pain questionnaire
comparison between groups, mean change from Day 0 to Day 21
Time frame: from Day 0 to Day 21
Assessment of patient satisfaction, assessed on 0 to 10 points scale (extremely dissatisfied = 0; extremely satisfied = 10)
comparison between groups, at Day 21
Time frame: at Day 21
Patient willingness to use the product in the future, assessed on 1 - 4 points scale (strongly disagree=1, disagree=2, agree=3, strongly agree=4)
comparison between groups, at Day 21
Time frame: at Day 21
Assessment of rescue product use (starting date and number of times the rescue product was used)
comparison among groups, at Day 21
Time frame: at Day 21