| CTRI Number |
CTRI/2018/10/016125 [Registered on: 23/10/2018] Trial Registered Prospectively |
| Last Modified On: |
10/01/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study of Ivermectin Lotion 0.5% w/w for the Treatment of Pediculus humanus capitis (head lice) Infestation |
|
Scientific Title of Study
|
A Comparative, Two arm, Randomized, Double blind, Parallel Group, Vehicle Controlled Clinical Study to Evaluate Efficacy and Safety of Ivermectin Lotion 0.5% w/w for the Treatment of Pediculus humanus capitis (head lice) Infestation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| APL/CT/16/10 |
Protocol Number |
| Version No.00, Dated Dec 23, 2016 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manjeet Ramteke |
| Designation |
Principal Investigator |
| Affiliation |
G. T. Hospital, Grant Govt. Medical College and J.J. Groups of Hospital |
| Address |
G. T. Hospital, Grant Govt. Medical College and J.J. Groups of Hospital, Lokmanya Tilak Marg, Fort, Mumbai- 400001, Maharashtra, India
Mumbai
MAHARASHTRA
400001
India |
| Phone |
919970284767 |
| Fax |
|
| Email |
manjeetramteke@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailesh Singh |
| Designation |
Sr Vice President R&D and Regulatory Affairs |
| Affiliation |
Ajanta Pharma Ltd |
| Address |
Ajanta Pharma Ltd, Advent 43AB/44BCD, Charkop Industrial Estate,
Kandivli West. Mumbai
Mumbai (Suburban)
MAHARASHTRA
400067
India
Mumbai (Suburban)
MAHARASHTRA
400067
India |
| Phone |
0226062111 |
| Fax |
|
| Email |
shailesh.singh@ajantapharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailesh Singh |
| Designation |
Sr Vice President R&D and Regulatory Affairs |
| Affiliation |
Ajanta Pharma Ltd |
| Address |
Ajanta Pharma Ltd, Advent 43AB/44BCD, Charkop Industrial Estate,
Kandivli West. Mumbai
Mumbai (Suburban)
MAHARASHTRA
400067
India
Mumbai (Suburban)
MAHARASHTRA
400067
India |
| Phone |
0226062111 |
| Fax |
|
| Email |
shailesh.singh@ajantapharma.com |
|
|
Source of Monetary or Material Support
|
| Ajanta Pharma Ltd, Advent 43 AB/44BCD, Charkop Industrial Estate, Kandivali West,
Mumbai. Maharashtra 400067 |
|
|
Primary Sponsor
|
| Name |
Ajanta Pharma Ltd |
| Address |
Advent 43 AB / 44BCD, Charkop Industrial Estate, Kandivali West.
Mumbai. Maharashtra 400067 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 16 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bimal Kanish |
Christian Medical College Ludhiana |
Department of Dermatology, Christian Medical College and Hospital, Brown Road, Ludhiana, Punjab-141008
Ludhiana
PUNJAB |
919814101367
drbimalkanish@yahoo.co.in |
| Dr Chitra Shivanand Nayak |
Department of Dermatology TN Medical College & BYL Nair Ch. Hospital |
BYL Nair Ch.Hospital & TNMC, Dr. Al Nair Road, Mumbai Central, Mumbai-400008
Mumbai
MAHARASHTRA |
9819107591
chitra212@hotmail.com |
| Dr Kranti Chandan Jaykar |
Department of Skin and VD Indira Gandhi Institute of Medical Sciences |
Department of skin and VD,
Indira Gandhi Institute of Medical Sciences, Sheikhpura Patna, Bihar-800014
Patna
BIHAR |
8969953194
drkcjaykar@yahoo.co.in |
| Dr Montu Deka |
Down Town Hospital Ltd |
Downtown Hospital, Dispur, G.S. Road, Guwahati-781006
Jorhat
ASSAM |
9435033901
drmontu_deka@yahoo.com |
| Dr Manjeet Ramteke |
G T Hospital, Grant Government Medical College & Sir J.J. Group of Hospital |
G T Hospital, Grant Government Medical College & Sir J.J. Group of Hospital, Mumbai-400009
Mumbai
MAHARASHTRA |
9970284767
manjeetramteke@gmail.com |
| Dr G Narsihma Rao Netha |
Gandhi Hospital |
Department of DVL, 5 th Floor, Gandhi Hospital, Musheerabad, Secunderabad, Telangana, India-500003
Hyderabad
ANDHRA PRADESH |
919390032196
04027504441
gnrnetha@gmail.com |
| Dr Patel Nayan Harshadbhai |
GCS Medical College, Hospital and Research Centre |
Gujarat Cancer Society Medical College, Hospital & Research Centre, Opp. DRM Office, Nr. Chamunda Bridge, Naroda Road Ahmedabad-380025, Gujarat, India.
Ahmadabad
GUJARAT |
919925011309
917922201915
patelnayan78.np@gmail.com |
| Dr Krina Bharatbhai Patel |
GMERS Medical College and Civil Hospital Sola |
GMERS Medical College and Civil Hospital, Sola, Nr. Gujarat High Court, S.G. Highway, Sola, Ahmedabad-380060, Gujarat, India.
Ahmadabad
GUJARAT |
919227222221
y2k_kbpatel@yahoo.com |
| Dr Dev Prakash Shivhare |
GSVM Medical College |
Department of Dermatology, GSVM Medical College, Swaroop Nagar, Kanpur-208002, U.P, India.
Kanpur Nagar
UTTAR PRADESH |
9450136374
dermatology.research786@gmail.com |
| Dr Devendra Yadav |
Jeevan Jyoti Multispecialty Hospital & Research Centre |
Jeevan Jyoti Multispecialty Hospital & Research Centre, 162, Bai ka Bagh, Lowther Road, Allahabad, Uttar Pradesh Pin-211003, India.
Allahabad
UTTAR PRADESH |
919415858634
dermaresearchjjh@gmail.com |
| Dr B Mohan Lal |
Kakatiya Medical College & Mahatma Gandhi Memorial Hospital |
Mahatma Gandhi Memorial Hospital, S.V.P Road Warangal-506007
Warangal
ANDHRA PRADESH |
9440116365
mohanlalbanoth73@gmail.com |
| Dr Surjit Singh Mehta |
Maharaja Agrasen Hospital |
Maharaja Agrasen Hospital, Punjabi Bagh, New Delhi-110026
New Delhi
DELHI |
01140777555
drsurjitmehta@gmail.com |
| Dr Shashi Kumar B |
Mandya Institute of Medical Sciences |
Mandya Institute of Medical Sciences, Mandya-571401, Karnataka
Mandya
KARNATAKA |
9886197902
shashibm@yahoo.com |
| Dr Savitha A S |
Rajalakshmi Hospital |
Rajalakshmi Hospital, 21/1, Lakshmipura Main Road, Vidyaranyapura Post, Bengaluru, Karnataka 560097
Bangalore
KARNATAKA |
9880512166
08023254855
drsavithasomaiah@gmail.com |
| Dr Ruchir Hitendrabhai Shah |
Sanjivani Super Speciality Hospital Pvt. Ltd. |
Sanjivani Super Speciality Hospital Pvt. Ltd. New Uday Park Society, Nr. Sunrise Park, Vasatrapur. Ahmedabad-380015, Gujarat, India.
Ahmadabad
GUJARAT |
919904079691
drruchirshah.dermatologist@gmail.com |
| Dr Yogesh Marfatia |
SSG Hospital and Medical College |
SSG Hospital and Medical College, Vadodara-390001
Vadodara
GUJARAT |
919825917442
ym11256@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| Ethics Committee Down Town Hospital |
Submittted/Under Review |
| Ethics Committee Indira Gandhi Institute of Medical Sciences (IGIMS) |
Approved |
| Ethics Committee MIMS Mandya |
Approved |
| Ethics Committee, GSVM Medical College |
Approved |
| GMERS Medical College |
Submittted/Under Review |
| Grant Government Medical College and Sir J. J. Group of Hospitals |
Approved |
| Institutional Ethics Committee IMS and SUM Hospital |
Submittted/Under Review |
| Institutional Ethics Committee Jeevan Jyoti Hospital and Research Centre |
Approved |
| Institutional Ethics Committee Maharaja Agrasen Hospital |
Submittted/Under Review |
| Institutional Ethics Committee on Human Research, Medical College Baroda |
Approved |
| Institutional Ethics Committee, Gandhi Medical College/ Hospital |
Submittted/Under Review |
| Institutional Ethics Committee, GCS Medical College, Hospital and Research Centre |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ivermectin Lotion 0.5% w/w |
One tube of lotion is to be applied for 10 minutes to coat the hair and scalp. Rinse off with water. Use sterile hand gloves during application of the lotion on hairs and scalp. |
| Comparator Agent |
Placebo Tablet similar to Test
Product. |
One tube of lotion is to be applied for 10 minutes to coat the hair and scalp. Rinse off with water. Use sterile hand gloves during application of the lotion on hairs and scalp. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| To evaluate the safety of Ivermectin Lotion 0.5% w/w Versus Vehicle Control in lice infested subjects |
at the end of 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="219"
Sample Size from India="219"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/10/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Yet Not |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A Comparative, Two arm, Randomized, Double blind,
Parallel Group, Vehicle Controlled Clinical Study to Evaluate Efficacy and
Safety of Ivermectin Lotion 0.5% w/w for the Treatment of Pediculus humanus capitis (head lice) Infestation
Primary
Objective: To evaluate the efficacy of Ivermectin Lotion 0.5% w/w
Versus Vehicle Control in lice infested subjects.
Secondary
Objective: To evaluate the safety of Ivermectin Lotion 0.5% w/w
Versus Vehicle Control in lice infested subjects. |