Striae DistensaeNCT02452359

Clinical Evaluation of Using Intense Pulsed Light for Improving the Appearance of Striae Distensae

A study testing Venus Versa in people with Striae Distensae, run by Venus Concept at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This trial is intended to evaluate the effect of IPL treatment on the Striae Distensae. The study hypothesis is that the SR580 applicator will improve the appearance of Striae Distensae by at least 1 point on the Global Aesthetic Improvement ScaleI (GAIS) at 3 months follow-up compared to baseline in at least 50% of… Read more about this study

Who is it for?: Ages 24 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Striae Distensae
What is being tested?: Venus Versa
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 1 siteUnited States
Study dates: 13 Mar 2015to 31 Mar 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 24 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Able to provide written Informed Consent;
Healthy male or female, 24-65 years Fitzpatrick-Goldman skin type I-V;
Having visible Striae Distensae to be treated (abdomen/thighs);
Comply with the treatment/follow-up schedule and requirements;
Women of child-bearing age are required to be using a reliable method of birth control

Who cannot join

Fitzpatrick-Goldman skin type VI;
Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 6 weeks after breastfeeding;
Heavy smoker
Unable or unlikely to refrain from tanning
Use of photosensitive medication
Use of oral isotretinoin within 3 months

Show all 26Show fewer

Any dermal/epidermal damage or disorder in treated area
Prior treatment in treated area within 3 months
Prior skin laser/light or another device treatment in treated area within 6 months
Prior use of collagen, fat injections or other methods of skin augmentation in treated area within 12 months
Prior use of Botox in treatment area within 6 months
Prior ablative resurfacing procedure with laser in treatment area within 12 months
Any other surgery in treated area within 9 months
Participation in a study of another investigational device or drug as per the Investigator's discretion
History of keloid or any other type of hypertrophic scar formation or poor wound healing in a previously injured skin area
Showing symptoms of hormonal disorders (such as Melasma, Chloasma);
Concurrent inflammatory skin conditions, open laceration or abrasion of any sort on area to be treated during the course of treatment
Active Herpes Simplex at the time of treatment or having experienced more than three episodes of Herpes Simplex eruption within a year of study
Multiple dysplastic nevi in area to be treated
Having a bleeding disorder or taking anticoagulation medications
History of immunosuppression/immune deficiency disorders
Having any form of active cancer at the time of enrollment and during the course of the study or history of skin cancer
Pigmented lesion in the treated area that appears cancerous
Significant concurrent illness, such as uncontrolled diabetes
Active infections in the treated area
28.Tattoo or permanent makeup at the treatment area. 29.Mentally incompetent, prisoner or evidence of active substance or alcohol abuse 30.Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study

Trial locations and contacts

1 site in 1 country.

United States1 site

Rosenberg Plastic Surgery
Beverly Hills, California, 90211

Other trials in United States

About this study

Official title: Clinical Evaluation of Venus Versa SR Applicator Using Intense Pulsed Light on Skin Texture for Improving the Appearance of Striae Distensae

Read the detailed description

Study Design This is a multi-site, prospective, open labeled clinical trial with before-after study design. This study will include up to 8 visits at the clinic: initial screening/consultation, 5 treatments, visits in 2 week intervals, and 2 follow-up visits at 1 and 3 months after the last treatment visit.

Up to 60 healthy subjects age 24-65 with Striae Distensae will be enrolled.

Study duration:

Duration of subject's participation: Up to 5.5 months from enrollment to termination

Blinding Objective assessment of clinical improvement by global assessment scale will be achieved by sending before/after pictures (baseline/3months after last treatment) to 3 blinded reviewers at the end of the study.

Study Procedures Test Spots Up to 3 test spots will be performed in the selected treatment area to determine the optimal parameters / settings

Treatment visits Each subject will be enrolled and scheduled for 5 treatments at 2 week intervals and return for follow-up visits at one month and 3 months after the last treatment for evaluation of the treated areas. The duration of the entire treatment visit is approximately 60 minutes.

Treatment The treatment areas are divided into 2 treatment areas: abdomen or thighs. Apply a thin layer of IPL gel. Place the applicator in close contact, perpendicular to the skin with no pressure applied. Pressing the applicator will fire the IPL pulse.

Administer pulses throughout the treated area to ensure full coverage of the treated area with applicator overlap approximately 1/3 of the previously treated skin.

A single pass over the area is completed Remove the remnants of the IPL gel and dry thoroughly. Cold air or cold, wet but not frozen gauze pads may be placed on the treated area for post treatment cooling.

Typical responses to the treatment are mild erythema and edema.

Conditions: Striae Distensae
Being tested: Venus Versa
Keywords: stretch marks
Medical subject headings: Striae Distensae

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Venus VersaDevice
The Venus Versa system consists of a console and 4 detachable applicators that deliver optical energy in the form of Intense Pulsed Light to the patient skin. The intense pulsed light lamp delivers non-coherent light distributed over a range of wavelengths from 500 nm to 1200 nm. Different filters are embedded in the different applicators so that each applicator can deliver the desired spectrum according to the indications to be treated.In this study, the IPL applicator SR580 will be evaluated for the treatment of Striae Distensae, depending on the patient's skin type.

Study groups in NCT02452359
Study group	Role	What they receive
Treatment Group	Experimental	Group receiving treatment with Venus Versa IPL energy Receives: Device: Venus Versa

What is being measured

The primary outcome is the main question the study is designed to answer.

Improvement in Striae Distensae Appearance
Striae distensae appearance improvement by at least 1 point on the Global Aesthetic Improvement scale (GAIS) from photographs 3 months following the last treatment as determined by 3 blinded reviewers where 3 = Very Much Improved, 2 = Much Improved, 1 = Improved, 0 = No Change, -1 = Worse, -2 = Much Worse and -3 = Very Much Worse.
Measured: 90 days following last IPL treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Mar 201531 Mar 2017

First posted22 May 2015 (estimated)
Study start13 Mar 2015
Primary completion15 Feb 2017
Study completion31 Mar 2017

Why it stopped: Continuing the trial was considered to be superfluous.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Striae DistensaeStudies 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
Model description: Open-label study where all subjects assigned to receive 5 treatments every 2 weeks. Subjects acted as their own control.
Masking: None (open label)
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02452359
Sponsor's protocol ID: CS0315
Status last verified: Oct 2020
First submitted: 8 May 2015
Last updated: 3 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Evaluating the Effectiveness and Safety of Microneedling With Topical Tranexamic Acid in Treatment of Striae Rubra
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All Striae Distensae trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of Venus Versa SR Applicator Using Intense Pulsed Light on Skin Texture for Improving the Appearance of Striae Distensae
ClinicalTrials.gov ID: NCT02452359
Acronym / sponsor ID: CS0315
Conditions: Striae Distensae
Keywords: stretch marks
Study type: Interventional
Recruitment status: TerminatedReason stopped: Continuing the trial was considered to be superfluous.
Enrolment: 54 participants (actual)
Lead sponsor: Venus ConceptIndustry (pharma, biotech, devices)
Study start: 13 Mar 2015 (actual)
Primary completion: 15 Feb 2017 (actual)
Study completion: 31 Mar 2017 (actual)
First posted: 22 May 2015 (estimated)
Results: Posted 3 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Up to 60 healthy subjects age 24-65 with Striae Distensae will be enrolled.

Study duration:

Duration of subject's participation: Up to 5.5 months from enrollment to termination

Study Procedures Test Spots Up to 3 test spots will be performed in the selected treatment area to determine the optimal parameters / settings

Administer pulses throughout the treated area to ensure full coverage of the treated area with applicator overlap approximately 1/3 of the previously treated skin.

Typical responses to the treatment are mild erythema and edema.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Open-label study where all subjects assigned to receive 5 treatments every 2 weeks. Subjects acted as their own control.

Arm	Type	Receives
Treatment Group	Experimental	Device: Venus VersaGroup receiving treatment with Venus Versa IPL energy

Who may qualify

Ages: 24 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Able to provide written Informed Consent;
Healthy male or female, 24-65 years Fitzpatrick-Goldman skin type I-V;
Having visible Striae Distensae to be treated (abdomen/thighs);
Comply with the treatment/follow-up schedule and requirements;
Women of child-bearing age are required to be using a reliable method of birth control

Key exclusion criteria (26 listed)

Fitzpatrick-Goldman skin type VI;
Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 6 weeks after breastfeeding;
Heavy smoker
Unable or unlikely to refrain from tanning
Use of photosensitive medication

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
Venus VersaThe Venus Versa system consists of a console and 4 detachable applicators that deliver optical energy in the form of Intense Pulsed Light to the patient skin. The intense pulsed light lamp delivers non-coherent light distributed over a range of wavelengths from 500 nm to 1200 nm. Different filters are embedded in the different applicators so that each applicator can deliver the desired spectrum according to the indications to be treated.In this study, the IPL applicator SR580 will be evaluated for the treatment of Striae Distensae, depending on the patient's skin type.	Device	Treatment Group

Primary outcome

Improvement in Striae Distensae Appearance
Time frame: 90 days following last IPL treatment
Striae distensae appearance improvement by at least 1 point on the Global Aesthetic Improvement scale (GAIS) from photographs 3 months following the last treatment as determined by 3 blinded reviewers where 3 = Very Much Improved, 2 = Much Improved, 1 = Improved, 0 = No Change, -1 = Worse, -2 = Much Worse and -3 = Very Much Worse.

Results and safety

Results posted to the registry on 3 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IPL 580 nm Treatment	54	33

Primary outcome: Improvement in Striae Distensae Appearance

Time frame: 90 days following last IPL treatment

Population analysed: The primary outcome measure is not reported as data not collected.

Adverse events

Time frame: 1 year 11 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IPL 580 nm Treatment	0 of 54 (0%)	0 of 54 (0%)	0 of 54

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Striae Distensae

Not yet recruiting
Evaluating the Effectiveness and Safety of Microneedling With Topical Tranexamic Acid in Treatment of Striae Rubra
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Recruiting
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RecruitingObservational study
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Not yet recruitingPhase 1
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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.

Tracey L Mancuso study director

Venus Concept

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Venus Versa in people with Striae Distensae, run by Venus Concept at 1 site in United States.

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 5 inclusion and 26 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: stopped early, as of the sponsor's last update on 3 Nov 2020. 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 United States. 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?

Yes. Results are posted in the registry (first posted 3 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Improvement in Striae Distensae Appearance (time frame: 90 days following last IPL treatment). 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 NCT02452359.

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 3 Nov 2020.