A Study of Ivermectin Lotion 0.5% w/w for the Treatment of Pediculus humanus capitis (head lice) Infestation
- Conditions
- Other specified local infections of the skin and subcutaneous tissue,
- Registration Number
- CTRI/2018/10/016125
- Lead Sponsor
- Ajanta Pharma Ltd
- Brief Summary
A Comparative, Two arm, Randomized, Double blind,Parallel Group, Vehicle Controlled Clinical Study to Evaluate Efficacy andSafety of Ivermectin Lotion 0.5% w/w for the Treatment of *Pediculus humanus capitis* (head lice) Infestation
PrimaryObjective: To evaluate the efficacy of Ivermectin Lotion 0.5% w/wVersus Vehicle Control in lice infested subjects.
SecondaryObjective: To evaluate the safety of Ivermectin Lotion 0.5% w/wVersus Vehicle Control in lice infested subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 219
- Subjects meeting all of the following criteria will be recruited for the trial: 1.Healthy males, non-pregnant females and children of age ≥6 months to ≤65 years (both inclusive) will be enrolled.
- 2.Subjects must have an active head lice infestation of atleast three live lice and/or viable nits.
- (Viability of nits to be determined by using magnifying lens at a distance of less than 0.6 cm/6 mm from the scalp).
- 3.Following application and rinsing of the test article, subject agrees not to shampoo, wash, or rinse their hair or scalp until the 24 hour post treatment evaluation has been completed.
- 4.Subject agrees not to cut or chemically treat their hair while participating in the study.
- 5.Subject and/or parent/guardian agree that the subject will not use any other form of lice treatment during the duration of the study.
- 6.Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
- Caregivers who are willing to sign Informed Consent agreement for children of age <7 years.
- Children of age ≥7 years who are willing to sign a child’s assent form.
- Subjects will be excluded if ANY of the following conditions apply: 1.Female subjects who are pregnant or lactating or planning to become pregnant during the study period.
- Females who are not ready to use acceptable contraceptive methods during the course of study.
- 2.Scalp condition that could make it difficult to evaluate the extent and severity of an infestation or that would present a problem in the evaluation of response to therapy (e.g. psoriatic scalp lesions, extensive seborrheic dermatitis).
- 3.Treatment for head lice (OTC, home remedy and/or prescription drugs) in the last 7 days.
- 4.Subject who used any hair dye, bleaches, hair straightening or permanent wave solution on the hair within 14 days of randomization.
- 5.Known history of irritation or sensitivity to pediculicides or hair care products.
- 6.Subjects with known allergy or hypersensitivity to Ivermectin or any component of the test product.
- 7.Any condition or illness that may compromise the objective of the protocol.
- 8.Subject receiving any other treatment which may interfere with the study results.
- 9.Participation in a previous investigational drug study within the past 30 days.
- 10.Does not understand the requirements for study participation and/or may likely exhibit poor compliance.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of Ivermectin Lotion 0.5% w/w Versus Vehicle Control in lice infested subjects. at the end of 2 weeks
- Secondary Outcome Measures
Name Time Method To evaluate the safety of Ivermectin Lotion 0.5% w/w Versus Vehicle Control in lice infested subjects at the end of 2 weeks
Trial Locations
- Locations (16)
Christian Medical College Ludhiana
🇮🇳Ludhiana, PUNJAB, India
Department of Dermatology TN Medical College & BYL Nair Ch. Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Department of Skin and VD Indira Gandhi Institute of Medical Sciences
🇮🇳Patna, BIHAR, India
Down Town Hospital Ltd
🇮🇳Jorhat, ASSAM, India
G T Hospital, Grant Government Medical College & Sir J.J. Group of Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Gandhi Hospital
🇮🇳Hyderabad, ANDHRA PRADESH, India
GCS Medical College, Hospital and Research Centre
🇮🇳Ahmadabad, GUJARAT, India
GMERS Medical College and Civil Hospital Sola
🇮🇳Ahmadabad, GUJARAT, India
GSVM Medical College
🇮🇳Nagar, UTTAR PRADESH, India
Jeevan Jyoti Multispecialty Hospital & Research Centre
🇮🇳Allahabad, UTTAR PRADESH, India
Scroll for more (6 remaining)Christian Medical College Ludhiana🇮🇳Ludhiana, PUNJAB, IndiaDr Bimal KanishPrincipal investigator919814101367drbimalkanish@yahoo.co.in