FindTrial
Sign In

A clinical trial to compare the systemic absorption of Malathion when applied locally on hair and scalp as either Malathion Gel 0.5% or Malathion 0.5% Lotion (Ovide) in patients with Head lice

A Randomized, Single-Dose, Parallel Group, Comparative Pharmacokinetic (PK) Study to Evaluate Malathion Gel 0.5% Versus Ovide (malathion) Lotion 0.5% in Patients with Pediculosis capitis

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2009/091/000266
Enrollment
Unknown
Registered
2009-05-19
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: Malathion Gel 0.5%: 0.5% malathion to be applied for duration of 30 minutes Control Intervention1: Ovide (malathion) 0.5% Lotion: Ovide (malathion) 0.5% lotion To Be Applied For 12 Hour

Sponsors

Taro Pharmaceuticals USA, Inc. 3 Skyline Drive Hawthorne, NY 10532 Phone: (914) 345-9001 Fax: (914) 345-9719
Lead Sponsor
Trident Clinical Research India Pvt. Ltd. B-907, Sagar Tech Plaza Andheri-Kurla Road Saki Naka Andheri (East) Mumbai 400072
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: - Adult Male or non-pregnant adult female (age 18 years or older), in good general health - Adult Patients presenting with Pediculosis capitis who meet Inclusion/Exclusion criteria and willing to be enrolled in this study - The Patient must be willing to consent to the treatment with Malathion Gel 0.5% or Ovide Lotion 0.5% and for blood drawings before and after medication administration.

Exclusion criteria

Exclusion criteria: - Individuals with history of irritation or sensitivity to pediculicides or hair care products - Individuals with any visible skin/scalp condition at the treatment site which, in the opinion of the investigative personnel, or Sponsor, will interfere with the evaluation. -Individuals previously treated with a pediculicide within 4 weeks of the study. -Individuals who exhibit potential signs and symptoms of cholinesterase inhibition. -Patients currently receiving sulfonamide antibiotics or ivermectin

Design outcomes

Primary

MeasureTime frame
1. Compare the Systemic Exposure of Malathion 0.5% Gel versus Ovide 0.5% Lotion 2. Compare the Safety of Both Malathion 0.5% ProductsTimepoint: 1. Systemic absoption - 48 hours 2. Safety assessment - 07 days—

Secondary

MeasureTime frame
The link between the systemic exposure and plasma and RBC cholinesterase activityTimepoint: 48 hours—

Countries

India

Contacts

Public ContactDr. Nilesh Patel

Head of Clinical Operations (Full-time employee of study site)

nileshp@dmricro.com02227642747

Outcome results

None listed

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