a Flexible Wound Dressing for the Management of Genital Skin Conditions

Stratpharma

Status: Completed

Conditions: Menopause Related Conditions; Atrophic Vaginitis; Lichen Planus; Vaginitis; Lichen Sclerosus

Treatments: Device: Film forming silicone gel (7-0940)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05396261

SPASMSX01 HALL

Details and patient eligibility

About

The objective of the study is to determine the efficacy of 7-0940 in the management of genital skin conditions in female patients

Enrollment: 54 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to provide informed consent
• Diagnosed genital skin condition

Exclusion criteria

• Unable to give informed consent
• Patient unable to apply topical device
• Allergy or intolerance to ingredients or excipients of the formulation of studied products

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

54 participants in 1 patient group

Treatment arm

Experimental group

Description:

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.

Treatment:

Device: Film forming silicone gel (7-0940)