Hair ReductionNCT06202274
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
A study testing Nordlys, Gentle, Picoway, Vbeam, Profound, Profound Matrix, eTwo, Exceed, CO2RE in people with Hair Reduction and Tattoo Removal, run by Candela Corporation at 3 sites in 2 countries.
Trial summary
This is a non-randomized, multi-center, open-label, prospective clinical study evaluating the clinical treatment with Candela Medical Technology. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hair Reduction, Tattoo Removal, Wrinkle
- What is being tested?
- Nordlys, Gentle, Picoway, Vbeam, Profound, Profound Matrix, eTwo, Exceed, CO2RE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 4 Oct 2023to 4 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age or older
- Fitzpatrick skin type I-VI
- Willingness to provide signed, informed consent to participate in the study
- Able and willing to comply with the treatment/follow-up schedule and requirements and pre and post treatment instructions.
- Willing to receive clinical treatments with the study device to be utilized and comply with all study (protocol) requirements.
- Willingness to allow photographs and/or video of treated areas, and to release their use for scientific/educational and/or promotional/marketing purposes
- Willing to abstain from any other procedures, medications or topicals in the study treatment areas for the duration of the study which the investigator deems would interfere with the study.
Who cannot join
- Pregnant or planning to become pregnant, or breast feeding during the study
- Skin cancer in the treatment area or history of melanoma in the treatment area
- History of current cancer and subject has undergone chemotherapy within the last 12 months
- Severe concurrent conditions, such as cardiac disorders, per investigator discretion
- Impaired immune system or use of immunosuppressive medications as deemed inappropriate per investigator discretion
- Herpes Simplex Virus (HSV) in the intended treatment area unless treated following a prophylactic regimen
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- Pacemaker or internal defibrillator or any active electrical implant anywhere in the body if to be treated with an RF based device
- Superficial metal or other implants in the treatment area, except superficial dental implants, unless these implants can be removed or covered with rolled gauze during treatment if to be treated with an RF based device
- Active skin condition in the treatment area such as skin infection, sores, psoriasis, eczema, rash, or open wounds as per discretion of the investigator
- History of abnormal wound healing, keloid, or hypertrophic scar formation, as well as very thin or fragile skin as per discretion of the investigator
- History of collagen vascular disease or vasculitic disorders as per discretion of the investigator
- Known allergy to medication to be used during treatments such as allergy to topical anesthetic (e.g. lidocaine)
- History of systemic corticosteroid therapy in past six months as per discretion of the investigator
- Tattoos or permanent makeup in the intended treatment area unless to be treated for tattoos or permanent makeup
- If to be treated for efficacy assessments, history of aesthetics treatments/procedures (e.g. facial resurfacing and deep chemical peeling) within the last 4 months within the intended treatment area, neuromodulator injections (e.g. Botox®), collagen, non-permanent dermal filler, or fat injections or other methods of augmentation with injected bio-material in the treated area within the last 3 months, permanent synthetic fillers (e.g. silicone) in the treatment area, absorbable facial threads within the last 1 year or non-absorbable facial threads within the intended treatment area, or surgery within the intended treatment area. History of prior treatments and procedures will be assessed per investigator discretion.
- In the opinion of the investigator, the subject is unwilling or unable to adhere to the study requirements or is otherwise unsuitable for the study.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Center for Morden Aesthetic Medicine
Jacksonville, Florida, 32207
Candela Institue for Excellence
Marlborough, Massachusetts, 01752
About this study
This is a non-randomized, multi-center, open-label, prospective clinical study evaluating the clinical treatment with Candela Medical Technology.
Read the detailed description
Subjects may receive treatment with one applicator or combination of any of the devices and applicators and/or additional commercial devices, products, and procedures. Evaluations may include combination treatments, sequential treatments, split face treatments, exploration of treatment and system parameters, and evaluation of exploratory indications. Treatments may include evaluation of commercial Candela systems with modification in hardware or software and/or treatment outside of treatment guidelines and exploratory indications (off-label) for evaluation of clinical feedback, device components, and treatment outcomes.
Subjects may receive up to twelve (12) treatments. Treatments may occur with a minimum treatment interval of 2 weeks and maximum treatment interval of 12 weeks. The number and interval of treatments will depend upon the device(s), treatment area, and indication to be treated. Follow-up visits may be required per PI discretion. Follow-up visits may occur virtually or in person.
- Conditions
- Hair Reduction, Tattoo Removal, Wrinkle, Acne, Scars, Benign Cutaneous Vascular Lesions
- Being tested
- Nordlys, Gentle, Picoway, Vbeam, Profound, Profound Matrix, eTwo, Exceed, CO2RE
- Medical subject headings
- Acne Vulgaris, Cicatrix, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nordlys, Gentle, Picoway, Vbeam, Profound, Profound Matrix, eTwo, Exceed, CO2REDevice
Subjects will receive up to twelve (12) treatments at minimum treatment interval of 2 weeks and maximum treatment interval of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 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. Receives: Device: Nordlys, Gentle, Picoway, Vbeam, Profound, Profound Matrix, eTwo, Exceed, CO2RE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS)
Subject assessment of treatment discomfort/pain immediately post-treatment via Numerical Rating Scale (NRS). Subjects will be presented a horizontal line scale and asked to make a mark along the scale. Subjects will be asked to rate pain from 0 to 10, with 0 equaling no pain and 10 equaling the worst possible pain. A number is obtained by measuring up to the point the participant has indicated.
Measured: From the first treatment to the last treatment, up 132 weeks.
Post-treatment Assessment Severity Scale
Skin responses including edema, erythema, pinpoint bleeding, purpura/ecchymosis, petechiae, and microscopic epithelial necrotic debris (MENDs) will be assessed immediately after treatment with a post-treatment assessment severity scale: grade 1 means absent, grade 2 means mild, grade 3 means moderate, and grade 3 means severe.
Measured: From the first treatment to the last treatment, up to 132 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start4 Oct 2023
- Primary completion4 Oct 2028 (estimated)
- Study completion4 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair ReductionStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Candela Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Konika P Schallen, MD, Principal investigator, Candela Institue for Exellence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202274
- Sponsor's protocol ID
- PM23001
- Status last verified
- Oct 2026
- First submitted
- 2 Jan 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
- ClinicalTrials.gov ID
- NCT06202274
- Acronym / sponsor ID
- PM23001
- Conditions
- Hair Reduction, Tattoo Removal, Wrinkle, Acne, Scars, Benign Cutaneous Vascular Lesions
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Candela CorporationIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- 4 Oct 2028 (estimated)
- Study completion
- 4 Oct 2029 (estimated)
- First posted
- 11 Jan 2024 (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.
This is a non-randomized, multi-center, open-label, prospective clinical study evaluating the clinical treatment with Candela Medical Technology.
Detailed description
Subjects may receive treatment with one applicator or combination of any of the devices and applicators and/or additional commercial devices, products, and procedures. Evaluations may include combination treatments, sequential treatments, split face treatments, exploration of treatment and system parameters, and evaluation of exploratory indications. Treatments may include evaluation of commercial Candela systems with modification in hardware or software and/or treatment outside of treatment guidelines and exploratory indications (off-label) for evaluation of clinical feedback, device components, and treatment outcomes.
Subjects may receive up to twelve (12) treatments. Treatments may occur with a minimum treatment interval of 2 weeks and maximum treatment interval of 12 weeks. The number and interval of treatments will depend upon the device(s), treatment area, and indication to be treated. Follow-up visits may be required per PI discretion. Follow-up visits may occur virtually or in person.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Nordlys, Gentle, Picoway, Vbeam, Profound, Profound Matrix, eTwo, Exceed, CO2RETreatment 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 18 years of age or older
- Fitzpatrick skin type I-VI
- Willingness to provide signed, informed consent to participate in the study
- Able and willing to comply with the treatment/follow-up schedule and requirements and pre and post treatment instructions.
- Willing to receive clinical treatments with the study device to be utilized and comply with all study (protocol) requirements.
Key exclusion criteria (16 listed)
- Pregnant or planning to become pregnant, or breast feeding during the study
- Skin cancer in the treatment area or history of melanoma in the treatment area
- History of current cancer and subject has undergone chemotherapy within the last 12 months
- Severe concurrent conditions, such as cardiac disorders, per investigator discretion
- Impaired immune system or use of immunosuppressive medications as deemed inappropriate per investigator discretion
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 |
|---|---|---|
| Nordlys, Gentle, Picoway, Vbeam, Profound, Profound Matrix, eTwo, Exceed, CO2RESubjects will receive up to twelve (12) treatments at minimum treatment interval of 2 weeks and maximum treatment interval of 12 weeks. | Device | Treatment |
Primary outcome
Numerical Rating Scale (NRS)
Time frame: From the first treatment to the last treatment, up 132 weeks.
Subject assessment of treatment discomfort/pain immediately post-treatment via Numerical Rating Scale (NRS). Subjects will be presented a horizontal line scale and asked to make a mark along the scale. Subjects will be asked to rate pain from 0 to 10, with 0 equaling no pain and 10 equaling the worst possible pain. A number is obtained by measuring up to the point the participant has indicated.
Post-treatment Assessment Severity Scale
Time frame: From the first treatment to the last treatment, up to 132 weeks.
Skin responses including edema, erythema, pinpoint bleeding, purpura/ecchymosis, petechiae, and microscopic epithelial necrotic debris (MENDs) will be assessed immediately after treatment with a post-treatment assessment severity scale: grade 1 means absent, grade 2 means mild, grade 3 means moderate, and grade 3 means severe.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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.
Konika P Schallen, MD principal investigator
Candela Institue for Exellence
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nordlys, Gentle, Picoway, Vbeam, Profound, Profound Matrix, eTwo, Exceed, CO2RE in people with Hair Reduction and Tattoo Removal, run by Candela Corporation at 3 sites in 2 countries.
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 7 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Israel. 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?
This study is still under way. Results are not available in the source record yet.
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?
Numerical Rating Scale (NRS) (time frame: From the first treatment to the last treatment, up 132 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026.