a Flexible Wound Dressing for the Management of Genital Skin Conditions

NCT05396261 | Completed

• 1 other identifier: SPASMSX01 HALL
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• gynaecological skin condition

  Likert scales to measure: * Dryness * Tissue thinning * Erosion/Ulcers * Fissures * Erythema * Scarring/adhesion * Contact bleeding * Bloodblisters * Greyish film * White lacy streaks

  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

Secondary Outcomes (1)

• patient symptoms

  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

Study Arms (1)

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.

Device: Film forming silicone gel (7-0940)

Interventions

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.

Treatment arm

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide informed consent
• Diagnosed genital skin condition

You may not qualify if:

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

Sponsors & Collaborators

• Stratpharma AG: lead

Study Sites (1)

St. Andrews War Memorial Hospital

Spring Hill, Queensland, 4000, Australia

Location

Related Publications (1)

• 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.

  PMID: 39035147 DERIVED

MeSH Terms

Conditions

Vaginitis; Atrophic Vaginitis; Lichen Planus; Lichen Sclerosus et Atrophicus

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Philip Hall, MD

  St. Andrews War Memorial Hospital - Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 31, 2022
• Study Start: January 31, 2018
• Primary Completion: January 1, 2022
• Study Completion: February 1, 2022
• Last Updated: May 31, 2022

Record last verified: 2022-05

Locations

AU (1)