Effects of permethrin 2.5% with tea tree oil topical gel in comparison with placebo on Demodex density and clinical features in rosacea patients: a double-blind, randomized clinical trial
Aimed to study the effects of permethrin 2/5% and Tea tree oil topical gel on Demodex density and clinical presentations in patients with rosacea.
Design
A double blind randomized clinical trial, with control group and parallel group design
Settings and conduct
35 patients were enrolled in the study. The patients referred to the Dermatology department at Bahman Hospital in Tehran from April 2016 to March 2017. Both patients and the researcher were blind to the contents of the tubes used for keeping drug/ placebo for the right and the left sides of the face.
Participants/Inclusion and exclusion criteria
Inclusion criteria; Papulopustular rosacea patients; At least 5 mites per square centimeter in the facial biopsy samples of both left and right sides; being at the age of at least 18 years old regardless of gender.
Non-inclusion criteria: Rosacea patients with less than 5 mites per square centimeter in the facial biopsy samples of one or both left and right sides; Patients with different types of skin cancers; Patients with severe skin infections; Patients with severe burning; Sensitivity to permethrine; Pregnant women; Breastfeeding women
Intervention groups
Intervention group: Each patient randomly applied the permethrin 2.5% with Tea tree oil gel on the clean skin of one side of the face twice a day for 12 weeks.
Placebo group: Each patient randomly applied the placebo gel on the clean skin of one side of the face twice a day for 12 weeks.
Main outcome variables
Density of Demodex mite; rosacea primary symptoms; rosacea secondary symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140304016837N4
Registration date:2019-01-14, 1397/10/24
Registration timing:retrospective
Last update:2019-01-14, 1397/10/24
Update count:0
Registration date
2019-01-14, 1397/10/24
Registrant information
Name
Kosar Raoufinejad
Name of organization / entity
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran,
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
k-raoufinejad@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
2017-04-06, 1396/01/17
Actual recruitment end date
2018-03-18, 1396/12/27
Trial completion date
2018-05-20, 1397/02/30
Scientific title
Effects of permethrin 2.5% with tea tree oil topical gel in comparison with placebo on Demodex density and clinical features in rosacea patients: a double-blind, randomized clinical trial
Public title
Effect of permethrin 2/5% with Tea tree oil in rosacea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with papulopustular Rosacea
At least 5 mites per square centimeter in the facial biopsy samples of both left and right sides
At least 18 years old, regardless of gender
Exclusion criteria:
Rosacea patients with less than 5 mites per square centimeter in the facial biopsy samples of one or both left and right sides
Patients with different types of skin cancers
Patients with severe skin infections; Patients with severe burnings
Sensitivity to permethrin
Pregnant women
Breastfeeding women
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
Actual sample size reached:
45
Randomization (investigator's opinion)
Randomized
Randomization description
The study groups were simply randomized based on flipping a coin. The “heads” were supposed as “right, permethrin 2.5% and Tea tree oil; left, placebo” and the “tails” were assumed as “left, permethrin 2.5% Tea tree oil ; right, placebo"
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double blind study ,the content of tube was kept unknown to the researcher and patients.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Medical Researches, Pharmaceutical Sciences Branch, Islamic Azad University, Teh
Street address
PO Box 19419, Yasaman St, Yakhchal Ave, Qolhak Ave, Shariati street
City
Tehran
Province
Tehran
Postal code
19419
Approval date
2017-02-13, 1395/11/25
Ethics committee reference number
IR.IAU.PS.REC.1395.42
Health conditions studied
1
Description of health condition studied
Rosacea
ICD-10 code
L71
ICD-10 code description
Rosacea
Primary outcomes
1
Description
Density of Demodex mites per centimeter squared of the facial surface on the left and right sides
Timepoint
Baseline and the 2nd, 5th, 8th, and 12th weeks after the initiation for both sides of the face
Method of measurement
Standard skin surface biopsy
Secondary outcomes
1
Description
Transient erythema,
Timepoint
Baseline and the 2nd, 5th, 8th, and 12th weeks after the initiation of the study
Method of measurement
The clinical presentations of both sides of the face were assessed by photography and the clinical criteria of the National Rosacea Society Scorecard
2
Description
Nontransient erythema
Timepoint
Baseline and the 2nd, 5th, 8th, and 12th weeks after the initiation of the study
Method of measurement
The clinical presentations of both sides of the face were assessed by photography and the clinical criteria of the National Rosacea Society Scorecard
3
Description
papules and pustules
Timepoint
Baseline and the 2nd, 5th, 8th, and 12th weeks after the initiation of the study
Method of measurement
The clinical presentations of both sides of the face were assessed by photography and the clinical criteria of the National Rosacea Society Scorecard
4
Description
Telangiectasia
Timepoint
Baseline and the 2nd, 5th, 8th, and 12th weeks after the initiation of the study
Method of measurement
The clinical presentations of both sides of the face were assessed by photography and the clinical criteria of the National Rosacea Society Scorecard
Intervention groups
1
Description
Each patient randomly applied the permethrin 2.5% with Tea tree oil gel on the clean skin of one side of the face twice daily for 12 weeks.
Category
Treatment - Drugs
2
Description
Control group: Each patient randomly applied the placebo gel on the clean skin of one side of the face twice daily for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Ward, Bahman Hospital, Tehran, Iran
Full name of responsible person
Dr. Parvin Mansouri
Street address
Bahman Hospital, North Iran-Zamin Street, Gharb township
City
Tehran
Province
Tehran
Postal code
1465795481
Phone
+98 21 8857 5901
Email
bahmanhospital@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Zahra Jafariazar
Street address
Yasaman Ave, Yakhchal St, Qolhak St, Shariati St.
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0051
Email
elnazebneyamin@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr.Elnaz Ebneyamin
Position
pharmaciae doctor
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Pharmaceutical Sciences Branch, Islamic Azad University, PO Box 19419, Yasaman St, Yakhchal Ave, Qolhak Ave, Shariati Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 8821 0291
Email
Elnazebneyamin@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Mehdi Rajabi
Position
Pharmacotherapy Specialist
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Pharmaceutical Sciences Branch, Islamic Azad University, PO Box 19419, Yasaman St, Yakhchal Ave, Qolhak Ave, Shariati Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2260 9043
Email
Mehdirj@aol.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr.Elnaz Ebneyamin
Position
Pharm.D
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Pharmaceutical Sciences Branch, Islamic Azad University, PO Box 19419, Yasaman Ave, Yakhchal St, Qolhak Ave, Shariati St.
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 8821 0291
Email
Elnazebneyamin@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available