Purpose: to evaluate the efficacy and safety of topical Naloxone® to control chronic pruritus in patients with neurodermitis. Design: This is a Phase I Randomized Controlled Clinical Trial Double Blind study on the patients with neurodermitis. Patients will randomly be assigned to two groups with 35 patients. Setting and conduct: Patients will be treated with an antihistamine (e.g. Citrizine® 10ml daily), as prescribed by a dermatologist. Patients in the treatment and control group will receive topical formulation of Naloxone® and placebo on the affected areas based on the FINGER TIP UNIT role, twice a day (morning and evening) for a period of 4 weeks. Participant: Patients who have been diagnosed with neurodermitis by a physicain. Intervention: Patients in the treatment group will receive topical formulation of Naloxone® on the affected areas, twice a day (morning and evening) for a period of 4 weeks. Main outcome measure: Pruritus score and Quality Life Quality Index
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201702231165N18
Registration date:2017-05-28, 1396/03/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-28, 1396/03/07
Registrant information
Name
Yunes Panahi
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8821 1524
Email address
yunespanahi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-03-05, 1395/12/15
Expected recruitment end date
2017-06-21, 1396/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy and safety of topical naloxone in control of chronic pruritus in patients with neurodermatitis
Public title
Evaluation of efficacy of topical Naloxone® in control of neurotic pruritus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The patient has no addiction; have not been treated with any form of topical steroids; diagnosis of neurodermitis has been confirmed by a physician; the content form should have been completed by the patient; age between 25 and 65 years; have no other skin disorders; accessible at all times during the trial; do not leave the treatment after one week; do not have allergy to the medication. Exclusion criteria: when disease become uncontrollable; severe reaction or allergy to the medication; patients’ age less the 25 and more than 65 years
Age
From 70 years old to 30 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
N/A
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of the Islamic Azad University of Pharmaceutical Science
Street address
Islamic Azad University of Pharmaceutical Science; Yasaman alley; Yakhchal street; Doctor shariatie; Tehran; Iran
City
TEHRAN
Postal code
19395-6466
Approval date
2016-03-16, 1394/12/26
Ethics committee reference number
IR.IAU.PS.REC.1394.44
Health conditions studied
1
Description of health condition studied
Neurodermatitis
ICD-10 code
L98.1
ICD-10 code description
Neurotic excoriation
Primary outcomes
1
Description
Severity of itching area
Timepoint
Before intervention; after intervention
Method of measurement
Standard Questionaries
2
Description
Distribution of itching area
Timepoint
Before intervention; after intervention
Method of measurement
Standard Questionaries
3
Description
Quality of life
Timepoint
Before intervention; after intervention
Method of measurement
Standard questionaries
Secondary outcomes
1
Description
Itching Freqency
Timepoint
Before intervention; After intervention
Method of measurement
Standard Questionaries
Intervention groups
1
Description
Control group: Patients in the control group will receive topical placebo formulation, twice daily (morning and evening) for a period of four weeks.
Category
Placebo
2
Description
Intervention group: The Patients in the treatment group will receive topical formulation of Naloxone® on the affected areas, twice a day (morning and evening) for a period of four weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Dr. Yunes Panahi
Street address
Nosrati Ave., South sheykhbahaee St., Mollasadra St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Baqiyatallah University of medical sciences
Full name of responsible person
Dr. Yunes Panahi
Street address
Baqiyatallah University of medical sciences, Sheykhbahaee St., Mollasadra St.,
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baqiyatallah University of medical sciences
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
Baqiatallah University of Medical Science
Full name of responsible person
Dr. Yunes Panahi
Position
Professor/ PharmD
Other areas of specialty/work
Street address
Baqiatallah University of Medical Science, Sheykh Bahaei St.,Mollasadra St.,
City
Tehran
Postal code
Phone
+98 21 8821 1524
Fax
Email
YUNESPANAHI@YAHOO.COM
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baqiatallah University of Medical Science
Full name of responsible person
Dr. Yunes Panahi
Position
Professor/ PharmD
Other areas of specialty/work
Street address
Baqiatallah University of Medical Science, Sheykh Bahaei St., Mollasadra St.
City
Tehran
Postal code
Phone
+98 21 8821 1524
Fax
Email
YUNESPANAHI@YAHOO.COM
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)