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Effects of permethrin 5% topical gel in comparison with placebo on Demodex density in rosacea patients: a double-blind, randomized clinical trial

Protocol summary

Summary
This one-centered, placebo-controlled, double-blind, randomized clinical trial aimed to study the effects of permethrin 5% topical gel on Demodex density and clinical presentations of rosacea patients. Papulopustular rosacea patients, 18 years or older, with at least 5 mites per square centimeter on both sides of the face, were eligible for this study. In all, 20 eligible patients referring to the Dermatology Ward of Imam Khomeini Hospital in Tehran, from May 2011 to Mar 2014, provided informed consent to participate in this survey. Each patient randomly applied permethrin 5% gel on one side, and simultaneously the placebo gel on the other side of the face twice daily for 12 weeks. Demodex densities per square centimeter of the facial surface on the left and right sides were determined by standard skin surface biopsy at the baseline and the 2nd, 5th, 8th, and 12th weeks after the initiation. The clinical presentations of both sides of the face were assessed by photography and the clinical criteria of the National Rosacea Society Scorecard in the mentioned weeks as well.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014030416837N1
Registration date: 2014-04-21, 1393/02/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-04-21, 1393/02/01
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
Deputy of Research, Pharmaceutical Sciences Branch, Islamic Azad University, Tehran, Iran
Expected recruitment start date
2011-05-22, 1390/03/01
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of permethrin 5% topical gel in comparison with placebo on Demodex density in rosacea patients: a double-blind, randomized clinical trial
Public title
Effects of permethrin on rosacea
Purpose
Treatment
Inclusion/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; 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 120 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The study groups were simply randomized based on flipping a coin. The “heads” were supposed as “right, permethrin 5%; left, placebo” and the “tails” were assumed as “left, permethrin 5%; right, placebo”. Therefore, 40 half-faces were randomly divided into two equal groups for the permethrin 5% or placebo (20 half-faces in each group). For blinding, the permethrin 5% and placebo gels were filled in separate similar tubes labeled as “right” and “left”. Labeling and grouping were performed by a third party. The researcher and patients did not know the contents of the tubes. Each patient randomly applied the permethrin 5% gel on the clean skin of one side of the face and the placebo gel on the other side, twice daily for 12 weeks.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Medical Researches, Pharmaceutical Sciences Branch, Islamic Azad University, Teh
Street address
Ethics Committee of Medical Researches, Pharmaceutical Sciences Branch, Islamic Azad University, PO Box 19419, Yasaman St, Yakhchal Ave, Qolhak Ave, Shariati Ave, Tehran, Iran
City
Tehran
Postal code
19419
Approval date
2011-03-13, 1389/12/22
Ethics committee reference number
15561

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 square centimeter 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
Demodex densities per square centimeter of the facial surface on the left and right sides were determined by standard skin surface biopsy at the baseline and the 2nd, 5th, 8th, and 12th weeks after the initiation.

Secondary outcomes

1

Description
Clinical presentations of rosacea patients including: transient erythema, nontransient erythema, papules and pustules, telangiectasia, burning or stinging, plaque, dry appearance, edema, ocular manifestations, and phymatous changes.
Timepoint
Baseline and the 2nd, 5th, 8th, and 12th weeks after the initiation for both sides of the face
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 at the baseline and the 2nd, 5th, 8th, and 12th weeks after the initiation.

Intervention groups

1

Description
Each patient randomly applied the permethrin 5% gel on the clean skin of one side of the face twice daily for 12 weeks.
Category
Treatment - Drugs

2

Description
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, Imam Khomeini Hospital, Imam Khomeini Medical Center, Tehran, Iran
Full name of responsible person
Dr. Parvin Mansouri
Street address
Dermatology Ward, Imam Khomeini Hospital, Imam Khomeini Medical Center, 1419733141, End of Keshavarz Blvd, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Research, Pharmaceutical Sciences Branch, Islamic Azad University, Tehran, Iran
Full name of responsible person
Dr. Orkideh Ghorban Dadras
Street address
Deputy of Research, Pharmaceutical Sciences Branch, Islamic Azad University, PO Box 19419, Yasaman St, Yakhchal Ave, Qolhak Ave, Shariati Ave, Tehran, Iran
City
Tehran
Grant name
8153
Grant code / Reference number
8153
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research, Pharmaceutical Sciences Branch, Islamic Azad University, Tehran, Iran
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
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Person responsible for general inquiries

Contact
Name of organization / entity
Department of Clinical Pharmacy, Pharmaceutical Sciences Branch, Islamic Azad University, Tehran, Ir
Full name of responsible person
Dr. Kosar Raoufinejad
Position
Pharm. D.
Other areas of specialty/work
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
Postal code
19419
Phone
+98 21 2260 9043
Fax
+98 21 2260 9043
Email
kosaraoofi@yahoo.com; kosaraoofi@gmail.com; mehdirj@aol.co.uk
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Clinical Pharmacy, Pharmaceutical Sciences Branch, Islamic Azad University, Tehran, Ir
Full name of responsible person
Dr. Mehdi Rajabi
Position
Pharmacotherapy Specialist
Other areas of specialty/work
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
Postal code
19419
Phone
+98 21 2260 9043
Fax
+98 21 2260 9043
Email
mehdirj@aol.co.uk; kosaraoofi@yahoo.com; kosaraoofi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department of Clinical Pharmacy, Pharmaceutical Sciences Branch, Islamic Azad University, Tehran, Ir
Full name of responsible person
Dr. Kosar Raoufinejad
Position
Pharm. D.
Other areas of specialty/work
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
Postal code
19419
Phone
+98 21 2260 9043
Fax
+98 21 2260 9043
Email
kosaraoofi@yahoo.com; kosaraoofi@gmail.com; mehdirj@aol.co.uk
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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