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A clinical trial to study the safety and efficacy of the LightSheer Duet 1060nm HS laser system

Clinical Evaluation of LightSheer Duet 1060nm HS Handpiece

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/01/004292
Enrollment
25
Registered
2014-01-06
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: LightSheer Duet 1060nm HS laser handpiece: Five laser hair removal treatment visits with 4-6 weeks interval and 3 follow up visits: 1, 3 and 6 months post fifth treatment visit. Control

Sponsors

Lumenis India Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Healthy adult, females or males (at least 80% female) older than 18 years of age with skin type I-VI; Having at least two suitable treatment areas for hair removal with dark brown or black hair;

Exclusion criteria

Exclusion criteria: • Active infections; • Dysplastic nevi; • Tattoos; • Significant concurrent skin conditions or any inflammatory skin conditions; • Active cold sores, open lacerations or abrasions; • Chronic or cutaneous viral, fungal, or bacterial diseases; • Deep suntan, recent suntan, sunburn or artificially tanned skin; • Current skin cancer • Treatment should not be attempted on patients with a history of skin cancer or pre-cancerous lesions at the treatment areas;

Design outcomes

Primary

MeasureTime frame
Efficacy Demonstrate temporary hair removal 4-6 weeks following 3 treatments. Safety To evaluate the safety of hair removal using the LightSheer Duet 1060nm in Fitzpatrick I-VI and tanned skin types. Timepoint: Post Treatment 3

Secondary

MeasureTime frame
â?¢ Demonstrate temporary hair removal 3 month following 5 treatments. â?¢ Demonstrate permanent hair reduction 6 months following 5 treatments. â?¢ Evaluate the immediate response following treatment as well as the subjectâ??s perception of the treatment. â?¢ Evaluate hair coarseness and color. â?¢ Evaluate length of the treatment. â?¢ Evaluate the tissue alterations at the follicular level.Timepoint: 3 and 6 months post Treatment 5

Countries

India

Contacts

Public ContactDr Sushil Tahiliani

Dr Sushil Tahiliani clinic

drsushiltt@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026