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
45 studies on the registry are indexed under Atrophic Vaginitis; 7 are open to participants now.
This study's enrollment of 54 is below the median of 69 across 40 interventional studies indexed under Atrophic Vaginitis.
Browse Atrophic Vaginitis studies →Stratpharma AG is the lead sponsor of 12 studies on the registry; 3 are open to participants now.
Compared within Atrophic Vaginitis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Vaginitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Ran from Jan 2018 to primary completion in Jan 2022, 47 months.
How these figures are worked out, and which studies are left out of them.
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