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

NCT06542341 | Completed

• 1 other identifier: DOC-5574 1/15/19
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Wrinkle

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Reduction in chest pigmentation

  7 weeks after first treatment intervention

Study Arms (1)

Active Light treatment Arm

EXPERIMENTAL

Treatment with red and near infra red light 5 x week for 6 weeks

Device: decoLITE (TN2037)

Interventions

decoLITE (TN2037) DEVICE

Red/Near infra red light therapy

Active Light treatment Arm

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Steven Baker: lead

Study Sites (1)

Suite A, Astor House

Sutton Coldfield, B742UG, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Blinded photography- images masked
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical trials Manager

Model Details: Open-label, single-centre trial.

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 7, 2024
• Study Start: September 24, 2020
• Primary Completion: December 4, 2020
• Study Completion: January 31, 2021
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)