Dermatology/Skin - OtherNCT03944278
Pilot Evaluation of Thulium Laser Alone or in Combination With Broad Band Light for Treatment of Dermatologic Conditions
A study testing Thulium Laser in people with Dermatology/Skin - Other, run by Sciton at 1 site in United States.
Trial summary
Evaluate the Thulium laser device for skin resurfacing procedures, or as a treatment for pigmented lesions (age or sun spots) or dyschromia; or cutaneous lesions such as, but not limited to, actinic keratosis, melasma, fine rhytides; or as a method of improving skin tone and skin texture Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dermatology/Skin - Other
- What is being tested?
- Thulium Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2019to 29 Sep 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female or Male, 18 years and older
- Fitzpatrick Skin Type I-VI
- Subject has visible signs of moderate sun-damages and/or aging facial skin with visible areas of fine rhytides, pigmentation, and erythema or telangiectasia.
- Desires non-ablative photo-revitalization of the skin.
- Subject must agree to not make any changes in their skin regimen for the duration of the study, including the follow-up period.
- Subject must be able to read, understand and sign the Informed Consent Form.
Show all 10Show fewer
- Must be willing and able to adhere to the treatment and follow-up schedule and post- treatment care instructions.
- Willing to have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treatment area every day for the duration of the study, including the follow-up period.
- Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
- Agree to not undergo any other procedure(s) in the treatment area during the study, such as laser- or light-based treatment, non-light based device treatment such as radiofrequency or ultrasound, injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler, chemical peel, or surgical procedure
Who cannot join
- Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
- Any type of prior cosmetic treatment to the target area within 3 months of study participation, such as laser or light-based procedures or surgery.
- Prior injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler in the target area within 1 week of study participation.
- History of malignant tumors in the target area.
- Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles.
- Pregnant and/or breastfeeding.
Show all 27Show fewer
- Having an infection, dermatitis or a rash in the treatment area.
- Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.
- Suffering from coagulation disorders or taking prescription anticoagulation medications.
- History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
- History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
- History of vitiligo, eczema, or psoriasis.
- History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
- History of seizure disorders due to light.
- Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.
- History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen.
- History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
- History of pigmentary disorders, particularly tendency for hyper- or hypo- pigmentation.
- Systemic use of retinoid, such as isotretinoin, or corticosteroid, as applicable, within 6 months of study participation.
- Topical use of retinoid, such as isotretinoin, corticosteroid or hydroquinone on the target area within 1 month of participation.
- Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
- Excessively tanned in areas to be treated, or unable/unlikely to refrain from tanning during the study (for example, subject's occupation requires regular sun exposure).
- Current smoker or history of smoking within 6 months of study participation.
- Has infectious disease
- Has been on long-standing systemic steroids (e.g. Prednisone, Dexamethasone)
- Has medical condition that may affect wound healing
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Evaluate the Thulium laser device for skin resurfacing procedures, or as a treatment for pigmented lesions (age or sun spots) or dyschromia; or cutaneous lesions such as, but not limited to, actinic keratosis, melasma, fine rhytides; or as a method of improving skin tone and skin texture
- Conditions
- Dermatology/Skin - Other
- Being tested
- Thulium Laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thulium LaserDevice
Thulium laser for skin resurfacing procedures
| Study group | Role | What they receive |
|---|---|---|
| Thulium Device | Experimental | 1927 Laser Treatment Receives: Device: Thulium Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Photography
Change in photography when compared to baseline using Physicians global assessement scale
Measured: 6 weeks post final treatment
Secondary outcomes (1)
Pain scores
Pain during treatment scored using Numeric pain scale 0-10, where 0 is least pain and 10 being maximum pain
Measured: Immediately after each treatment received
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start12 Apr 2019
- Primary completion30 Aug 2020
- Study completion29 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatology/Skin - OtherStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sciton
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jay Patel, Study director, Sciton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03944278
- Sponsor's protocol ID
- S-18-TB01
- Status last verified
- Oct 2020
- First submitted
- 6 May 2019
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of Thulium Laser Alone or in Combination With Broad Band Light for Treatment of Dermatologic Conditions
- ClinicalTrials.gov ID
- NCT03944278
- Acronym / sponsor ID
- S-18-TB01
- Conditions
- Dermatology/Skin - Other
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- ScitonIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2019 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 29 Sep 2020 (actual)
- First posted
- 9 May 2019 (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.
Evaluate the Thulium laser device for skin resurfacing procedures, or as a treatment for pigmented lesions (age or sun spots) or dyschromia; or cutaneous lesions such as, but not limited to, actinic keratosis, melasma, fine rhytides; or as a method of improving skin tone and skin texture
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thulium Device | Experimental | Device: Thulium Laser1927 Laser Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Female or Male, 18 years and older
- Fitzpatrick Skin Type I-VI
- Subject has visible signs of moderate sun-damages and/or aging facial skin with visible areas of fine rhytides, pigmentation, and erythema or telangiectasia.
- Desires non-ablative photo-revitalization of the skin.
- Subject must agree to not make any changes in their skin regimen for the duration of the study, including the follow-up period.
Key exclusion criteria (27 listed)
- Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
- Any type of prior cosmetic treatment to the target area within 3 months of study participation, such as laser or light-based procedures or surgery.
- Prior injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler in the target area within 1 week of study participation.
- History of malignant tumors in the target area.
- Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles.
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 |
|---|---|---|
| Thulium LaserThulium laser for skin resurfacing procedures | Device | Thulium Device |
Primary outcome
Photography
Time frame: 6 weeks post final treatment
Change in photography when compared to baseline using Physicians global assessement scale
1 secondary outcome
Pain scores
Time frame: Immediately after each treatment received
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 20 Oct 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Dermatology/Skin - Other
RecruitingObservational study
Cutaneous and Mucosal Manifestations of Neurofribromatosis Type 2 in Children Under 15
Neurofibromatosis 2, Dermatology/Skin - Other
Recruiting
Application of the Belle.AI Dermatological Image Reference System for Patient Diagnosis in an Active Clinical Setting
Skin Condition, Dermatology
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.
Jay Patel study director
Sciton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thulium Laser in people with Dermatology/Skin - Other, run by Sciton 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 10 inclusion and 27 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 20 Oct 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?
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?
Photography (time frame: 6 weeks post final treatment). 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 20 Oct 2020.