WrinkleNCT06542341
Study to Evaluate the Efficacy of the décoLITE LED Device in Treating the Signs of Skin Aging of the décolletage Area
A study testing decoLITE (TN2037) in people with Wrinkle, run by Steven Baker at 1 site in United Kingdom.
Trial summary
To assess the efficacy of the décoLITE LED system in reducing the signs of skin aging of the décolletage area one week after a six-week treatment course. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkle
- What is being tested?
- decoLITE (TN2037)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Sep 2020to 31 Jan 2021
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy female, 30 to 65 years of age.
- Fitzpatrick phototype I-VI skin.
- Gave written informed consent.
- Photoaging of the décolletage area.
- Agreed NOT to use anti-aging products that contain active ingredients such as retinol and glycolic acid on the treatment area during the study period.
- Agreed NOT to undergo any aesthetic treatments (such as chemical peels, microdermabrasion, laser surfacing, etc.) in the treatment area during the study period
Who cannot join
- Suffering from a systemic photosensitive disorder such as Lupus erythematosus, photosensitive eczema, or Albinism.
- Currently taking (or with a history of taking) medication that is known to induce photosensitivity.
- Having known malignancy and/or undergoing chemotherapy, radiotherapy, or high doses of corticosteroids.
- Suffering from keloid scars or birth marks in the treatment area.
- Suffering from eczema, psoriasis, or skin rashes in the treatment area.
- Had used an anti-aging product within the 4 weeks prior to commencing the study.
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- Underwent plastic surgery within the last 6 months.
- Pregnant, breast-feeding, or wishing to become pregnant during the study period.
- Being enrolled in another clinical trial during the same study period.
- Having a planned hospital admission and/or surgical procedure for an illness or disease which existed before enrollment into the clinical trial, and which may interfere with the course or outcome of the study.
- Having medical or psychological condition(s) associated with a risk of poor protocol compliance (e.g., alcoholism or drug abuse).
- Undergoing or is likely to undergo other treatments of the décolletage area.
Trial locations and contacts
1 site in 1 country.
About this study
To assess the efficacy of the décoLITE LED system in reducing the signs of skin aging of the décolletage area one week after a six-week treatment course.
Read the detailed description
This was an open-label, single-center trial. Subjects carried out 5 treatments on separate days each week for 6 weeks. The plan for the study was to recruit 25 subjects to consider any dropouts to arrive at a final study total of 20.
Treatments were of 10 minutes duration using a combination of red (630nm) and near infrared (830nm) emitted from light emitting diodes. The device emitted 30mW/cm2 of light, delivering a dose of 18J/cm2 per treatment.
Subjects were assessed at baseline, at 5 weeks, and at 7 weeks (one week after the last treatment).
Assessments included separate evaluations of lines and pigment of the décolletage using the validated scale developed by Landau et al. by the principal investigator and a third party blinded physician, standardized photography, and recording of safety incidents. Subjective responses were based on treatment efficacy and ease of use of the device.
- Conditions
- Wrinkle
- Being tested
- decoLITE (TN2037)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
decoLITE (TN2037)Device
Red/Near infra red light therapy
| Study group | Role | What they receive |
|---|---|---|
| Active Light treatment Arm | Experimental | Treatment with red and near infra red light 5 x week for 6 weeks Receives: Device: decoLITE (TN2037) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in chest lines at rest
Reduction in chest lines at rest according to the validated Merz aesthetics décolleté grading scale developed by Landau, et al (2016).
Measured: 7 weeks after first treatment intervention
Secondary outcomes (1)
Reduction in chest pigmentation
Reduction in chest pigmentation according to the validated Merz aesthetics décolleté grading scale developed by Landau, et al (2016
Measured: 7 weeks after first treatment intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start24 Sep 2020
- Primary completion4 Dec 2020
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinkleStudies 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, single-centre trial.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steven Baker
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Steven Baker, Ismart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542341
- Sponsor's protocol ID
- DOC-5574 1/15/19
- Status last verified
- Aug 2024
- First submitted
- 31 Jul 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share- confidential regulatory data
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Efficacy of the décoLITE LED Device in Treating the Signs of Skin Aging of the décolletage Area
- ClinicalTrials.gov ID
- NCT06542341
- Acronym / sponsor ID
- DOC-5574 1/15/19
- Conditions
- Wrinkle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Steven BakerIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 4 Dec 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 7 Aug 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.
To assess the efficacy of the décoLITE LED system in reducing the signs of skin aging of the décolletage area one week after a six-week treatment course.
Detailed description
This was an open-label, single-center trial. Subjects carried out 5 treatments on separate days each week for 6 weeks. The plan for the study was to recruit 25 subjects to consider any dropouts to arrive at a final study total of 20.
Treatments were of 10 minutes duration using a combination of red (630nm) and near infrared (830nm) emitted from light emitting diodes. The device emitted 30mW/cm2 of light, delivering a dose of 18J/cm2 per treatment.
Subjects were assessed at baseline, at 5 weeks, and at 7 weeks (one week after the last treatment).
Assessments included separate evaluations of lines and pigment of the décolletage using the validated scale developed by Landau et al. by the principal investigator and a third party blinded physician, standardized photography, and recording of safety incidents. Subjective responses were based on treatment efficacy and ease of use of the device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, single-centre trial.
| Arm | Type | Receives |
|---|---|---|
| Active Light treatment Arm | Experimental | Device: decoLITE (TN2037)Treatment with red and near infra red light 5 x week for 6 weeks |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy female, 30 to 65 years of age.
- Fitzpatrick phototype I-VI skin.
- Gave written informed consent.
- Photoaging of the décolletage area.
- Agreed NOT to use anti-aging products that contain active ingredients such as retinol and glycolic acid on the treatment area during the study period.
Key exclusion criteria (12 listed)
- Suffering from a systemic photosensitive disorder such as Lupus erythematosus, photosensitive eczema, or Albinism.
- Currently taking (or with a history of taking) medication that is known to induce photosensitivity.
- Having known malignancy and/or undergoing chemotherapy, radiotherapy, or high doses of corticosteroids.
- Suffering from keloid scars or birth marks in the treatment area.
- Suffering from eczema, psoriasis, or skin rashes in the treatment area.
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 |
|---|---|---|
| decoLITE (TN2037)Red/Near infra red light therapy | Device | Active Light treatment Arm |
Primary outcome
Reduction in chest lines at rest
Time frame: 7 weeks after first treatment intervention
Reduction in chest lines at rest according to the validated Merz aesthetics décolleté grading scale developed by Landau, et al (2016).
1 secondary outcome
Reduction in chest pigmentation
Time frame: 7 weeks after first treatment intervention
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 7 Aug 2024.
- Individual participant dataSharing planned: No. No plan to share- confidential regulatory data
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing decoLITE (TN2037) in people with Wrinkle, run by Steven Baker at 1 site in United Kingdom.
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 12 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 7 Aug 2024. 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 Kingdom. 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?
Reduction in chest lines at rest (time frame: 7 weeks after first treatment intervention). 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 7 Aug 2024.