DyschromiaNCT02693054
Safety and Efficacy Study for Various Skin Conditions
A study testing HALO in people with Dyschromia and Photodamaged Skin, run by Sciton.
Trial summary
Characterizing safety and efficacy of Halo Laser Treatment for Various Skin Conditions. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dyschromia, Photodamaged Skin
- What is being tested?
- HALO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Dec 2016
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fitzpatrick Skin types I to IV
- Desires improvement of significant skin conditions on the face and/or neck
- Willingness to participate in the study by signing an informed consent form
- Will have limited sun exposure for at least two weeks prior to study screening and during the study, including the follow-up period
- Able to adhere to the treatment and follow-up schedule and post-treatment care instructions
- Post-menopausal or surgically sterilized female subjects.
Who cannot join
- History of Halo or resurfacing procedures in the treatment area within past six months
- Has tanned within the past thirty days or unable or unlikely to refrain from tanning, including the use of tanning booths, tanning spray, or cream
- Has tattoos, dysplastic nevi in the treatment area
- Pregnant and/or lactating
- Is planning to get pregnant within the study period
- Has a known history of photosensitivity
Show all 17Show fewer
- Has used medication with photosensitizing properties within the past six months, e.g. isotretinoin
- History or evidence of chronic or recurring skin disease or disorder (e.g. psoriasis, --Netherton syndrome, etc.) affecting the treatment area
- Has open lacerations, abrasions, active cold sores, or herpes sores
- Has hormonal disorders
- History of keloid or hypertrophic scar formation or poor wound healing
- History of immunosuppression or immune deficiency disorder (including HIV infection or AIDS) or use of immunosuppressive medications
- History of bleeding disorder or taking anticoagulation medications
- History of skin cancer or any other cancer in the treatment area
- Has significant concurrent illnesses, such as diabetes, lupus, epilepsy, or cardiac disorders, which might be aggravated as a result of treatment
- Has participated in any clinical trial involving an investigational drug or cosmetic product or procedure within the past thirty days
- The investigator feels that for any reason the subject is not eligible to participate in the study
About this study
Official title: Characterizing Safety and Efficacy of Halo Hybrid Fractional Laser Treatments for Various Skin Conditions
Characterizing safety and efficacy of Halo Laser Treatment for Various Skin Conditions.
Read the detailed description
The purpose of this study is to demonstrate safety and efficacy of Halo treatment as measured by changes in skin tone, texture and pigment.
- Conditions
- Dyschromia, Photodamaged Skin
- Being tested
- HALO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HALODevice
Laser Treatment
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Fractional Laser Treatment | Experimental | Halo (1470nm and 2940 nm) laser Receives: Device: HALO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in skin conditions assessed by photographs
Assessment of photographs by blinded evaluators
Measured: 6 months
Secondary outcomes (1)
Subject satisfaction post final treatment
Assessment of subject satisfaction with treatment result using survey/questionnaire
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyschromiaStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sciton
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Pozner, MD, Principal investigator, Sanctuary Plastic SurgeryChristopher Robb, MD, Principal investigator, Skin and Allergy CenterElizabeth Tanzi, MD, Principal investigator, Capital Laser and Skin CareJill Waibel, MD, Principal investigator, Miami Dermatology and Laser Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693054
- Sponsor's protocol ID
- HALOCIP001
- Status last verified
- Apr 2018
- First submitted
- 8 Feb 2016
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Safety and Efficacy of Halo Hybrid Fractional Laser Treatments for Various Skin Conditions
- ClinicalTrials.gov ID
- NCT02693054
- Acronym / sponsor ID
- HALOCIP001
- Conditions
- Dyschromia, Photodamaged Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- ScitonIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 Feb 2016 (estimated)
- 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.
Characterizing safety and efficacy of Halo Laser Treatment for Various Skin Conditions.
Detailed description
The purpose of this study is to demonstrate safety and efficacy of Halo treatment as measured by changes in skin tone, texture and pigment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hybrid Fractional Laser Treatment | Experimental | Device: HALOHalo (1470nm and 2940 nm) laser |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Fitzpatrick Skin types I to IV
- Desires improvement of significant skin conditions on the face and/or neck
- Willingness to participate in the study by signing an informed consent form
- Will have limited sun exposure for at least two weeks prior to study screening and during the study, including the follow-up period
- Able to adhere to the treatment and follow-up schedule and post-treatment care instructions
Key exclusion criteria (17 listed)
- History of Halo or resurfacing procedures in the treatment area within past six months
- Has tanned within the past thirty days or unable or unlikely to refrain from tanning, including the use of tanning booths, tanning spray, or cream
- Has tattoos, dysplastic nevi in the treatment area
- Pregnant and/or lactating
- Is planning to get pregnant within the study period
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 |
|---|---|---|
| HALOLaser Treatment | Device | Hybrid Fractional Laser Treatment |
Primary outcome
Improvement in skin conditions assessed by photographs
Time frame: 6 months
Assessment of photographs by blinded evaluators
1 secondary outcome
Subject satisfaction post final treatment
Time frame: 3 months
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 18 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Dyschromia
Active, not recruiting
A Phase 4 Clinical Study to Investigate the Effectiveness and Safety of Skin Resurfacing
Skin Resurfacing
RecruitingObservational study
Dental Dyschromia and Quality of Life in Early Prolonged Hyperbilirubinemia
Dental Diseases
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.
Jason Pozner, MD principal investigator
Sanctuary Plastic Surgery
Christopher Robb, MD principal investigator
Skin and Allergy Center
Elizabeth Tanzi, MD principal investigator
Capital Laser and Skin Care
Questions about this trial
What is this clinical trial studying?
A study testing HALO in people with Dyschromia and Photodamaged Skin, run by Sciton.
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 6 inclusion and 17 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 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Improvement in skin conditions assessed by photographs (time frame: 6 months). 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 18 Apr 2018.