An interventional study of Film forming silicone gel (7-0940) in Vaginitis, Atrophic Vaginitis and Lichen Planus, sponsored by Stratpharma AG. Completed at 1 site in Australia. Open to female participants. Per ClinicalTrials.gov, last updated 2022-05-31.
Sponsored by Stratpharma AG · Not applicable, Interventional, and Treatment
The objective of the study is to determine the efficacy of 7-0940 in the management of genital skin conditions in female patients
Exclusion Criteria:
Film forming silicone gel (7-0940) is an innovative gel that forms a full contact, flexible wound dressing for supporting mucosal conditions of the genital, rectal and perineal areas. Film forming silicone gel (7-0940) is a semi-occlusive, non-resorbable, self-drying and transparent gel. Film forming silicone gel (7-0940) may be directly applied to dry, wet, cracked and sensitive mucosal tissue. Film forming silicone gel (7-0940) gel is bacteriostatic and inert. It contains no alcohols, parabens or fragrances.
Device: Film forming silicone gel (7-0940)
Anecdotal evidence suggests that genital conditions in women associated with vaginal atrophy improve with the use of film-forming silicone dressings.
gynaecological skin condition
Likert scales to measure: * Dryness * Tissue thinning * Erosion/Ulcers * Fissures * Erythema * Scarring/adhesion * Contact bleeding * Bloodblisters * Greyish film * White lacy streaks
Time frame: Duration of the therapy will be according to physician's clinical practice. The average is 3 visits over a period of 3 to 6 months
patient symptoms
Likert scales to measure: * Pruritus/itchiness * Tender/sore * Swelling * Dryness * Burning of skin * Dyspareunia * Stinging with urination/clothes * Defecating pain/burning
Time frame: Duration of the therapy will be according to physician's clinical practice. The average is 3 visits over a period of 3 to 6 months
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Stratpharma AG