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Device

Treatment for Scarring

N/A

Recruiting

Led By Konika P Schallen

Research Sponsored by Candela Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years of age or older

Able and willing to comply with the treatment/follow-up schedule and requirements and pre and post treatment instructions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the first treatment to the last treatment, up 132 weeks.

Awards & highlights

Study Summary

This trial is a study that will evaluate the effectiveness of a medical treatment called Candela Medical Technology. It will be conducted at multiple centers and will be open to participants.

Who is the study for?

Adults over 18 with any skin type can join this study if they're willing to follow the treatment plan, allow photos for research and marketing, and avoid other treatments in the area during the study. Pregnant or breastfeeding individuals, those with recent cancer treatments, severe health conditions, impaired immune systems, certain implants or active skin issues are excluded.Check my eligibility

What is being tested?

The trial is testing Candela Medical Technology devices like Nordlys and Vbeam on various skin conditions including hemangioma and acne. It's an open-label study where everyone knows what treatment they're getting. Participants will be treated at multiple centers.See study design

What are the potential side effects?

Potential side effects may include discomfort at the treatment site, redness, swelling, blistering or changes in skin pigmentation. There might also be a risk of scarring or infection depending on individual responses to the technology.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can follow the treatment and check-up schedule.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the first treatment to the last treatment, up 132 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the first treatment to the last treatment, up 132 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the first treatment to the last treatment, up 132 weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Numerical Rating Scale (NRS)

Post-treatment Assessment Severity Scale

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

Treatment will be performed with commercial products manufactured by Candela and may also include non-Candela products. All devices will be used per the manufacturer's instructions.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Candela CorporationLead Sponsor

19 Previous Clinical Trials

1,465 Total Patients Enrolled

Konika P SchallenPrincipal InvestigatorCandela Institue for Exellence

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current sample size of patients involved in this clinical investigation?

"Indeed, the information available on clinicaltrials.gov indicates that this particular clinical trial is actively seeking eligible individuals. The study was initially posted on October 4th, 2023 and has been recently updated as of January 2nd, 2024. In order to reach its objectives, the trial aims to enroll a total of 500 participants across three different sites."

Answered by AI

Is the recruitment phase for this study still ongoing?

"Indeed, the clinicaltrials.gov information confirms that this study is currently in the process of recruiting eligible individuals. The trial was initially posted on October 4th, 2023 and has been recently updated as of January 2nd, 2024. A total of 500 participants are being sought across three designated sites."

Answered by AI