NCT06542341

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Steven Baker · Industry
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Wrinkle

Interventions

Type	Name	Description
DEVICE	decoLITE (TN2037)	Red/Near infra red light therapy

Timeline

• Start date: 2020-09-24
• Primary completion: 2020-12-04
• Completion: 2021-01-31
• First posted: 2024-08-07
• Last updated: 2024-08-07

Locations

1 site across 1 country: United Kingdom