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Ha44 0.74% w/w

Phase 2

Head Lice Infestation | Small molecule | Infectious Disease |Dr. Reddy's Laboratories Ltd|Last Updated: May 12, 2020

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment22

FDA Designations

No designations recorded

Clinical trial landscape

Ha44 0.74% w/w · 1 trial · 1 indication

Phase 2 1
NCT02010333A Pediatric Safety and Pharmacokinetics Study of Ha44 Gel Administered Topically for Treatment of Head Lice InfestationHead Lice Infestation
COMPLETED22 Analytics
PHASE2COMPLETED
A Pediatric Safety and Pharmacokinetics Study of Ha44 Gel Administered Topically for Treatment of Head Lice Infestation
Head Lice InfestationUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability of Ha44 Gel
8 months

Clinically significant changes in Physical Examinations, vital signs, safety laboratory tests and assessments of scalp and eye irritation and Electrocardiogram. The frequency and severity of Adverse Events.

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Ha44 Gel 0.74% w/wEXPERIMENTALOpen label, one arm

Interventions

NameTypeDescription
Ha44 Gel 0.74% w/wDRUGHA44 Gel 0.74% comprises of Abametapir as the active pharmaceutical ingredient and Benzyl Alcohol as one of the excipients.
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Eligibility Criteria

Age Range6 Months to 2 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Male or female, 6months \< 3years of age 2. Good health 3. Active head lice infestation defined as the presence of at least 3 live lice 4. Dermatological condition of scalp (at least G2 erythema or pruritus with evidence of excoriation/inflammation) 5. Parent/guardian agrees ...

Countries:United States
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Frequently asked questions about Ha44 0.74% w/w

What is Ha44 0.74% w/w used for?

Ha44 0.74% w/w is a small molecule drug being developed for the treatment of head lice infestation. It is administered topically as a gel. The drug is currently in Phase 2 clinical development and is being studied for use in pediatric patients.

Who makes Ha44 0.74% w/w?

Ha44 0.74% w/w is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker symbol RDY. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in patients with head lice infestation.

What phase is Ha44 0.74% w/w in?

Ha44 0.74% w/w is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial has been completed to assess its safety and pharmacokinetics in pediatric patients with head lice infestation.

What clinical trials is Ha44 0.74% w/w in?

Ha44 0.74% w/w has one completed clinical trial, identified as NCT02010333. This was a Phase 2 study titled 'A Pediatric Safety and Pharmacokinetics Study of Ha44 Gel Administered Topically for Treatment of Head Lice Infestation.' The trial enrolled 22 participants in the United States and included children as young as 6 months.

How does Ha44 0.74% w/w work?

Ha44 0.74% w/w is a small molecule drug applied topically as a gel for the treatment of head lice infestation. Its specific molecular target has not been disclosed in available information, so the exact mechanism of action is not detailed here.