Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice

Pediculosis Clinical Trial

Official title:

A Multi-Center Phase III Study to Evaluate Ovide Lotion 0.5% Formulation, for the Control of Head Lice in Pediatric Subjects and Adult Subjects With Pediculosis Capitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00927472
• Other study ID #: MALG-0817
• Status: Completed
• Phase: Phase 3
• First received: June 23, 2009
• Last updated: July 9, 2014
• Start date: August 2009
• Est. completion date: June 2010

Study information

• Verified date: July 2014
• Source: Taro Pharmaceuticals USA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

In this study, Malathion Gel 0.5% will be compared to Nix (permethrin 1%) as a treatment for head lice in patients 2 years of age and older. Malathion Gel 0.5% is a new formulation of an established head lice treatment. The new formulation has been evaluated in 2 previous studies of patients 2 years of age and older.

Description:

This is a Phase III, multi-center, investigator-blinded, two-arm, randomized, parallel group study, evaluating the safety and efficacy of a Malathion Gel, 0.5% formulation, manufactured by Taro. The objective is to show superiority of the novel product to an active control, Nix® Crème Rinse, manufactured by Insight Pharmaceuticals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: June 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

• Confirmed active head lice infestation

Exclusion Criteria:

• Allergy to pediculicides or hair care products

• Scalp conditions other than head lice

• Previous head lice treatment within the past 4 weeks

• Current antibiotic treatment

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lice Infestations
• Pediculosis

Intervention

Drug:
• Malathion gel 0.5%
Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present.
• Permethrin 1% rinse
Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present.

Locations

Country	Name	City	State
United States	Investigator Site	Bentonville	Arkansas
United States	Investigator Site	Jonesboro	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Taro Pharmaceuticals USA

Country where clinical trial is conducted

United States, 

References & Publications (1)

Meinking TL, Vicaria M, Eyerdam DH, Villar ME, Reyna S, Suarez G. A randomized, investigator-blinded, time-ranging study of the comparative efficacy of 0.5% malathion gel versus Ovide Lotion (0.5% malathion) or Nix Crème Rinse (1% permethrin) used as labeled, for the treatment of head lice. Pediatr Dermatol. 2007 Jul-Aug;24(4):405-11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Index Subjects Free of Any of Lice 14 Days After Their Last Treatment.	Treatment Success was evaluated using the Efficacy Intention to Treat (eITT) (LOCF) Efficacy ITT (eITT) was considered definitive.; The primary efficacy variable was the proportion of index subjects who were considered a Treatment Success 14 days after their last treatment (Day 14 visit if only treated on Day 1, Day 21 visit if treated on Day 1 and Day 7).; Index subject: 95 from 254 randomized (the youngest subject in the household who met index case criteria( having nits and at least 3 live lice))	3 weeks	No
Primary	Proportion of Index Subjects Lice-free 2 Weeks After Their Last Treatment	Treatment Success in the Efficacy Intention to Treat (eITT) (No LOCF); The primary efficacy variable was the proportion of index subjects who were considered a Treatment Success 14 days after their last treatment (Day 14 visit if only treated on Day 1, Day 21 visit if treated on Day 1 and Day 7).	3 weeks	No
Primary	Proportion of Index Subjects Lice-free 14 Days After Their Last Treatment	Treatment Success in the Per Protocol Population (PPP); The PPP included all subjects who complied strictly with the protocol and had outcome data for all required visits. Superiority analysis in the PPP was considered to be supportive.	3 weeks	No
Primary	Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit.(LOCF)	Treatment Success in the Modified Intention to Treat (Modified ITT) (LOCF); The Modified ITT included all randomized subjects who were treated and returned for at least one post-treatment visit. Subjects with missing efficacy data were included first with LOCF and then with non-LOCF	3 weeks	No
Primary	Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit (Non-LOCF).	Treatment Success in the Modified ITT (non-LOCF); The Modified ITT included all randomized subjects who were treated and returned for at least one post-treatment visit.; Subjects with missing efficacy data were included first with LOCF and then with non-LOCF	3 weeks	No
Secondary	Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (LOCF))	Treatment Success in the Efficacy ITT (LOCF); The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.	3 weeks	No
Secondary	Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (Non LOCF))	Treatment Success in the Efficacy ITT (non LOCF); The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.	3 weeks	No
Secondary	Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the PPP	Treatment Success in the PPP; The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.; The evaluations in the PPP was considered supportive.	3 weeks	No
Secondary	Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF)	Treatment Success in the Modified ITT (LOCF); The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.; The evaluations in the Modified ITT was considered supportive.	3 weeks	No
Secondary	Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (Non LOCF)	Treatment Success in the Modified ITT (non LOCF); The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.; The evaluations in the Modified ITT was considered supportive.	3 weeks	No