Safety, Efficacy and Preventative Effect of a Head Lice Product (X92001483) vs. Nix Creme Rinse (1% Permethrin).

Conditions

• Lice; Head Lice

Eligibility Criteria

Sex

ALL

Age

1 Year - N/A

Healthy Volunteers

Not accepted

Interventions

• Medical Device (X92001483) — DEVICE
  Treatment of subjects with Head Lice with a medical device (X92001483) with a physical mode of action on day 0, day 7, day 10, day 13 and day 14.

Study Details

To compare the safety, effectiveness, and preventive benefits of a medical device (X92001483) against Nix Cream Rinse (1% Permethrin) in people with head lice

Key Dates

Start date

May 1, 2026

Status verified

Jun 2026

Primary completion

Sep 30, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

98 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Medical Device X92001483
  Treatment of subjects with head Lice with the standard of care product Nix Creme Rinse on day 0 and day 7, followed by intermediate application of the medical device (X92001483) with a physical mode of action applied every 3 days.
• No Intervention: Nix Cream Rinse (1% Permethrin)
  Treatment of subjects with Head Lice with Nix Cream Rinse (1% Permethrin) with a physical mode of action on day 0 and day 7.

Primary Outcome Measure

Preventative Effect [ Time Frame: 14 days ]

Central Contacts

• Katie Shepherd
  561-635-2884
  [email protected]

Locations (1)

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