Status:
COMPLETED
Study to Evaluate the Efficacy of the décoLITE LED Device in Treating the Signs of Skin Aging of the décolletage Area
Lead Sponsor:
Steven Baker
Conditions:
Wrinkle
Eligibility:
All Genders
30-65 years
Phase:
NA
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 arr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2021
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06542341
Start Date
September 24 2020
End Date
January 31 2021
Last Update
August 7 2024
Active Locations (1)
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1
Suite A, Astor House
Sutton Coldfield, United Kingdom, B742UG