Clinical trial to compare efficacy and safety of the
Ivermectin 0.5% lotion and Permethrin 1% shampoo for treatment of pediculus humanus capitis infestation.
This study aims to determine therapeutic efficacy and safety of the Ivermectin 0.5% topical lotion compared with topical Permethrin 1% in subjects with Pediculus Humanus Capitis infestation. This is a multi central, randomized, double-blind two-arm clinical trial. 88 patients participate in each treatment group. Participants are healthy male and female subjects who are at least 6 months of age and infested with pediculus humanus capitis. Eligible subjects will randomly receive either the Ivermectin 0.5% lotion or topical Permethrin 1% as the treatment and they will be blinded to their type of treatment. Follow-up visits will performed on days 1, 7 and 14 by a trained evaluator. Evaluations will include presence or absence of live lice on the scalp and safety assessments. Primary outcome will be the percentage of patients in both groups with no live lice viable eggs (eggs found within 1.27 cm of the scalp) on the scalp. The secondary outcomes will be observed skin/scalp reactions and ocular irritation assessments.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016071320514N5
Registration date:2016-10-17, 1395/07/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-10-17, 1395/07/26
Registrant information
Name
Alireza Firooz
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 8190
Email address
firozali@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Gilaranco pharmaceutical and cosmetic company.
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial to compare efficacy and safety of the
Ivermectin 0.5% lotion and Permethrin 1% shampoo for treatment of pediculus humanus capitis infestation.
Public title
Efficacy and safety assessment of the topical Ivermectin 0.5% in pediculus capitis infestation.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: at least 6 months of age; presence of at least 3 live lice or 10 viable eggs (eggs found within 1.27 cm of the scalp); participants with good general health; signing the written informed consent by the capable participants or by their legal guardians for incapable ones; agree not to use any other forms of lice treatments except the test items; agrees not to cut their hair while participating in the study. Exclusion Criteria: history of irritation or sensitivity to Ivermectin or its components or other pediculicides products; presence of visible skin/scalp condition(s) that are not attributable to head lice infestation, such as an erythema score >2, blisters or vesicles at the treatment site ; presence of eczema or atopic dermatitis at the treatment site; history of treatment for head lice include OTC, home remedy or Rxin during the last 7 days; any condition or illness that, in investigator’s opinion, may compromise the objective of the protocol; pregnancy, lactation or planning to become pregnant during the study; participation in a previous investigational drug study within the past 30 days; prior participation in any Ivermectin trials
Age
From 6 months old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
176
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization performed based on block randomization method.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Room 105 , 5th floor, Central building of Tehran University of Medical Sciences , Ghods intersection , Keshavarz blvd.
City
Tehran
Postal code
Approval date
2016-04-16, 1395/01/28
Ethics committee reference number
IR.TUMS.REC.1395.2399
Health conditions studied
1
Description of health condition studied
Pediculus Humanus Capitis infestation.
ICD-10 code
B85.0
ICD-10 code description
Pediculosis due to Pediculus humanus capitis
Primary outcomes
1
Description
Percentage of patients in both groups with no live lice or viable eggs (eggs found on hair within 1.27 cm of the scalp) on the scalp examination
Timepoint
Before treatment and 1, 7 and 14 day after treatment
Method of measurement
Physical exam by a trained evaluator
Secondary outcomes
1
Description
Observed skin/scalp reactions and periocular skin irritation
Timepoint
Before treatment and 1, 7 and 14 day after treatment.
Method of measurement
Physical exam by a trained evaluator.
Intervention groups
1
Description
Intervention group: topical Ivermectin lotion, product from Gilaranco company contains Ivermectin 0.5%, once.
The whole bottle of the lotion should directly applied on dry hair and scalp and stayed on hair and scalp for 10 minutes after it has been applied. Then the lotion should completely rinsed from hair and scalp using only water.
Category
Treatment - Drugs
2
Description
Control group: Topical Permethrin shampoo, product from Gilaranco company contains 1% Permethrin, twice with one week interval.
the whole bottle of the product should be apply on the wet hair and scalp only and stayed on hair and scalp for 10 minutes after it has been applied. Then it should rinsed with warm water. The patients should also towel-dry the hair and comb out any tangles.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Dr.Maryam Daneshpazhooh
Street address
Vahdat-Eslami Square
City
Tehran
2
Recruitment center
Name of recruitment center
Dr.Zargari skin clinic
Full name of responsible person
Dr.Omid Zargari
Street address
Dana building, Boosar Bridge
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gilaranco pharmaceutical and cosmecutical company
Full name of responsible person
Najmeh Farahani
Street address
No 6, 4th Floor, Baradaran Shadab Street, North Iranshahr St
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gilaranco pharmaceutical and cosmecutical company
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Center for Research & Training in Skin Diseases & Leprosy
Full name of responsible person
Alireza Firooz
Position
Dermatologist and professor of Tehran University of Medical Sciences
Other areas of specialty/work
Street address
No 415, Taleqani avenue.
City
Tehran
Postal code
1416613675
Phone
+98 21 8897 8190
Fax
+98 21 8897 8190
Email
crtsdl_head@tums.ac.ir
Web page address
crtsdl.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Center for Research & Training in Skin Diseases & Leprosy
Full name of responsible person
Alireza Firooz
Position
Dermatologist and professor of Tehran University of Medical Sciences
Other areas of specialty/work
Street address
No 415, Taleqani avenue.
City
Tehran
Postal code
1416613675
Phone
+98 21 8897 8190
Fax
+98 21 8897 8190
Email
crtsdl_head@tums.ac.ir
Web page address
crtsdl.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Center for Research & Training in Skin Diseases & Leprosy
Full name of responsible person
Aniseh Samadi
Position
General practitioner
Other areas of specialty/work
Street address
No 415, Taleqani avenue.
City
Tehran
Postal code
1416613675
Phone
+98 21 8896 3804
Fax
+98 21 8896 3804
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)