VaginitisNCT05396261
a Flexible Wound Dressing for the Management of Genital Skin Conditions
A study testing Film forming silicone gel (7-0940) in people with Vaginitis and Atrophic Vaginitis, run by Stratpharma AG at 1 site in Australia.
Trial summary
The objective of the study is to determine the efficacy of 7-0940 in the management of genital skin conditions in female patients Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Vaginitis, Atrophic Vaginitis, Lichen Planus
- What is being tested?
- Film forming silicone gel (7-0940)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteAustralia
- Study dates
- 31 Jan 2018to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Able to provide informed consent
- Diagnosed genital skin condition
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Australia1 site
St. Andrews War Memorial Hospital
Spring Hill, Queensland, 4000
About this study
Official title: Post-marketing Surveillance of a Flexible Wound Dressing for the Management of Genital Skin Conditions
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
- Being tested
- Film forming silicone gel (7-0940)
- Medical subject headings
- Vaginitis, Atrophic Vaginitis, Lichen Planus, Lichen Sclerosus et Atrophicus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Film forming silicone gel (7-0940) |
What is being measured
The primary outcome is the main question the study is designed to answer.
gynaecological skin condition
Likert scales to measure:
- Dryness
- Tissue thinning
- Erosion/Ulcers
- Fissures
- Erythema
- Scarring/adhesion
- Contact bleeding
- Bloodblisters
- Greyish film
- White lacy streaks
Measured: 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
Likert scales to measure:
- Pruritus/itchiness
- Tender/sore
- Swelling
- Dryness
- Burning of skin
- Dyspareunia
- Stinging with urination/clothes
- Defecating pain/burning
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start31 Jan 2018
- Primary completion1 Jan 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VaginitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stratpharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Hall, MD, Principal investigator, St. Andrews War Memorial Hospital - Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396261
- Sponsor's protocol ID
- SPASMSX01 HALL
- Status last verified
- May 2022
- First submitted
- 19 May 2022
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39035147
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Surveillance of a Flexible Wound Dressing for the Management of Genital Skin Conditions
- ClinicalTrials.gov ID
- NCT05396261
- Acronym / sponsor ID
- SPASMSX01 HALL
- Conditions
- Vaginitis, Atrophic Vaginitis, Lichen Planus, Lichen Sclerosus, Menopause Related Conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Stratpharma AGIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to determine the efficacy of 7-0940 in the management of genital skin conditions in female patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Device: Film forming silicone gel (7-0940)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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Able to provide informed consent
- Diagnosed genital skin condition
Key exclusion criteria (3 listed)
- Unable to give informed consent
- Patient unable to apply topical device
- Allergy or intolerance to ingredients or excipients of the formulation of studied products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Treatment arm |
Primary outcome
gynaecological skin condition
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
Likert scales to measure: * Dryness * Tissue thinning * Erosion/Ulcers * Fissures * Erythema * Scarring/adhesion * Contact bleeding * Bloodblisters * Greyish film * White lacy streaks
1 secondary outcome
patient symptoms
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Derived from this study: PubMed 39035147Hall 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.
Related trials for Vaginitis
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
Randomized, Open-label
Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Hall, MD principal investigator
St. Andrews War Memorial Hospital - Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Film forming silicone gel (7-0940) in people with Vaginitis and Atrophic Vaginitis, run by Stratpharma AG at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gynaecological skin condition (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05396261, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.