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The objective of the study is to determine the efficacy of 7-0940 in the management of genital skin conditions in female patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Film forming silicone gel (7-0940) | Device | Anecdotal evidence suggests that genital conditions in women associated with vaginal atrophy improve with the use of film-forming silicone dressings. |
| Measure | Description | Time Frame |
|---|---|---|
| gynaecological skin condition | Likert scales to measure:
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| patient symptoms | Likert scales to measure:
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Hall, MD | St. Andrews War Memorial Hospital - Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Andrews War Memorial Hospital | Spring Hill | Queensland | 4000 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39035147 | Derived | Hall P. A Feasibility Study Investigating a Topical Preparation as Novel Adjunct Treatment for the Symptomatic Management of Vulvovaginal Skin Conditions. Womens Health Rep (New Rochelle). 2024 May 17;5(1):444-452. doi: 10.1089/whr.2024.0026. eCollection 2024. |
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| ID | Term |
|---|---|
| D014627 | Vaginitis |
| D059268 | Atrophic Vaginitis |
| D008010 | Lichen Planus |
| D018459 | Lichen Sclerosus et Atrophicus |
| ID | Term |
|---|---|
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D017512 | Lichenoid Eruptions |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |