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Low-Dose Ha44 0.37% w/w

Phase 2

Pediculosis | Small molecule | Dermatology |Dr. Reddy's Laboratories Ltd|Last Updated: Apr 29, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment142

FDA Designations

No designations recorded

Clinical trial landscape

Low-Dose Ha44 0.37% w/w · 1 trial · 1 indication

Phase 2 1
NCT01336647An Efficacy and Safety Study of Ha44 Gel Administered Topically for the Treatment of Head Lice InfestationPediculosis
COMPLETED142 Analytics
PHASE2COMPLETED
An Efficacy and Safety Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation
PediculosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants Who Are Lice Free at All Follow-up Visits (Day 1, 7 and 14) Through the Day 14 Visit
Follow up visit at days 1, 7 and 14 days

Secondary Endpoints

Safety and Tolerability of Ha44 Gel
From treatment to last visit of the study at 14 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTALGroup A Low-Dose Ha44 Gel 0.37% w/w topically administered to head and scalp.Single application for 10 minutes.
Group BEXPERIMENTALGroup B High-Dose Ha44 Gel 0.74% w/w. Topically administered to hair and scalp. Single application for 10 minutes of duration.
Group CPLACEBO_COMPARATORGroup C Placebo/ vehicle Ha44 Gel. Topically administered to hair and scalp.Single application for 10 minutes of duration.

Interventions

NameTypeDescription
Group A - Low-Dose Ha44 0.37% w/wDRUGLow Dose Ha44 Gel applied to scalp and hair for 10 minutes
Group B - High Dose Ha44 Gel 0.74% w/wDRUGHigh Dose Ha44 Gel applied to scalp and hair for 10 minutes
Group C - PlaceboDRUGPlacebo- vehicle Ha44 Gel without active ingredient applied to scalp and hair for 10 minutes
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Eligibility Criteria

Age Range2 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * 2 years of age or older * Body weight of at least 33 pounds * Has an active head lice infestation at Day 0. An active infection is defined as at least 3 live lice for the index subject and at least 1 live louse for the other household members * Belong to a household of no more...

Countries:United States
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