Adults 25 to 65, female only, with Skin Laxity. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
General Skin Appearance of Mons Pubis and LabiaPrimary· Baseline - Day 1, Follow-up visit - Day 85
Improvement in general skin appearance at follow-up visit 3 as compared to baseline as assessed by independent blinded evaluator by photographic assessment, utilizing the Global Aesthetic Improvement Scale (GAIS) where 3 = very much improved, 2 = much improved, 1 = improved, 0 = no change, -1 = worse, -2 = much worse and -3 = very much worse where higher scores indicate a better outcome.
GAIS Very Much Improved
Group
Value
95% CI
Venus Freeze Diamond Polar
3
GAIS Much Improved
Group
Value
95% CI
Venus Freeze Diamond Polar
4
GAIS Improved
Group
Value
95% CI
Venus Freeze Diamond Polar
1
Visual Analogue Scale (VAS)Secondary· Treatment 1 - Day 1, Treatment 2 - Day 29, Treatment 3 - Day 57
The subject records their measure of discomfort and pain associated with all treatments of the labia as a vertical line drawn on a 100 mm horizontal line on which the discomfort and pain intensity is represented by a point between the extremes of "no pain at all" (a value of 0 mm) and "worst pain imaginable (a value of 100 mm).
Treatment 1
Group
Value
95% CI
VAS - Labia Treatment
1.6
0.1 – 7.3
Treatment 2
Group
Value
95% CI
VAS - Labia Treatment
1.7
0.2 – 7.9
Treatment 3
Group
Value
95% CI
VAS - Labia Treatment
1.9
0.1 – 6.6
Visual Analog Scale (VAS)Secondary· Treatment 1 - Day 1, Treatment 2 - Day 29, Treatment 3 - Day 57
The subject records their measure of discomfort and pain associated with all treatments of the mons pubis as a vertical line drawn on a 100 mm horizontal line on which the discomfort and pain intensity is represented by a point between the extremes of "no pain at all" (a value of 0 mm) and "worst pain imaginable (a value of 100 mm).
Treatment 1
Group
Value
95% CI
VAS - Mons Pubis Treatment
1.2
0.1 – 3.8
Treatment 2
Group
Value
95% CI
VAS - Mons Pubis Treatment
0.9
0.1 – 2.8
Treatment 3
Group
Value
95% CI
VAS - Mons Pubis Treatment
1.2
0.1 – 3.5
Vaginal pHSecondary· Treatment 1 - Day 1, Treatment 2 - Day 29, Treatment 3 - Day 57, Follow-up visit - Day 85
Vaginal pH was obtained at each study visit. The pH is a numeric value from 0 to 14 expressing the acidity or alkalinity of the vaginal fluids where 7 is neutral, lower values are more acidic (value of 0) and higher values more alkaline (value of 14). A healthly vaginal pH has a value of 3.8 to 4.5.
Treatment 1
Group
Value
95% CI
Vaginal pH
4.5
3.9 – 4.8
Treatment 2
Group
Value
95% CI
Vaginal pH
4.3
3.9 – 4.5
Treatment 3
Group
Value
95% CI
Vaginal pH
4.4
4.2 – 4.5
Follow up Visit
Group
Value
95% CI
Vaginal pH
4.3
4.1 – 4.5
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data was collected for 3 months and 2 days..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The study will confirm that the Freeze Diamond polar applicator is safe for treating the Mons pubis and Labia, and will result in improvement in general skin appearance including an improvement in skin irregularities and skin laxity.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Venus Concept
Last refreshed: 17 April 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02770287.