Study to Evaluate the Efficacy of the décoLITE LED Device in Treating the Signs of Skin Aging of the décolletage Area

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.

Study Overview

• Status: Completed
• Conditions: Wrinkle
• Intervention / Treatment: Device: decoLITE (TN2037)

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Sutton Coldfield, United Kingdom, B742UG
    • Suite A, Astor House

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Light treatment Arm; Treatment with red and near infra red light 5 x week for 6 weeks	Device: decoLITE (TN2037); Red/Near infra red light therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	7 weeks after first treatment intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in chest pigmentation	Reduction in chest pigmentation according to the validated Merz aesthetics décolleté grading scale developed by Landau, et al (2016	7 weeks after first treatment intervention

Collaborators and Investigators

• Sponsor: Steven Baker

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2020
• Primary Completion (Actual): December 4, 2020
• Study Completion (Actual): January 31, 2021

Study Registration Dates

• First Submitted: July 31, 2024
• First Submitted That Met QC Criteria: August 4, 2024
• First Posted (Actual): August 7, 2024

Study Record Updates

• Last Update Posted (Actual): August 7, 2024
• Last Update Submitted That Met QC Criteria: August 4, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: DOC-5574 1/15/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share- confidential regulatory data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No