Wrinkle
Conditions
Brief 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.
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.
Interventions
DEVICEdecoLITE (TN2037)
Red/Near infra red light therapy
Sponsors
Steven Baker
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Blinded photography- images masked
Intervention model description
Open-label, single-centre trial.
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in chest lines at rest | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in chest pigmentation | 7 weeks after first treatment intervention | Reduction in chest pigmentation according to the validated Merz aesthetics décolleté grading scale developed by Landau, et al (2016 |
Countries
United Kingdom
Outcome results
None listed