The main goal of this study will be evaluation the efficacy and safty of topical naloxone in control of chronic pruritus Induced By Chemical Injuries. Patients who have been diagnosed by physition randomly divided in two groups with a sample size of 35 persons. This study is a double blind RCT(randomise clinical trial). The study population are patients with a clinical diagnosis of chronic pruritus induced by chemical injuries. They will be a candidate for this study. Inclusion criteria: 1. not addicted to opioids; 2. not treated with topical steroids; 3. diagnosis of chronic pruritus induced by chemical injuries confirmed by physition. The patients will enter randomly in two groups of 35 patients. Patients in both group (intervention and control) shuold be receive topical formulation of naloxone in the morning and evening for 4 weeks. (finger tip unit) on the affected areas. Our expected consequences is reducing the severity and extent of itching area. All the above will be evaluation base on standard questionaires such as pruritus score and DLQI .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201702221165N17
Registration date:2017-03-29, 1396/01/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-29, 1396/01/09
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
Personal
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 the Efficacy and Safety of Topical Naloxane Ointment on Controlling of Chronic Prupritus Induced By Chemical Injuries
Public title
Evaluation the efficacy of topical naloxane on Controlling of Chronic Prupritus Induced By Chemical Injuries
Purpose
Treatment
Inclusion/Exclusion criteria
1. self-satisfiction form should be filled by the patient; 2. the patients shouled be between 25-65 years old; 3. the Rx of pruritus induced by chemical gas shouled be diagnosed; 4. the patients shouldn’t have any other skin disorders; 5. the patients don’t use any topical steroids; 6. the patients shouldn’t be addict; 7. the patients be accessible; 8. the patients don’t leave the treatment more than one week; 9. the patients don’t have allergy to drug; 10. if the disease become uncontrolabe.
Age
From 25 years old to 65 years old
Gender
Both
Phase
2-3
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
The persons who are studied should not be addict.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran Azad University of Pharmaciutical Sciences
Street address
Azad University of Pharmaciutical Sciences. Yakhcal St. Dr Shariati street
City
Tehran
Postal code
19395-6466
Approval date
2016-03-16, 1394/12/26
Ethics committee reference number
IR.IAU.PS.REC.1394.45
Health conditions studied
1
Description of health condition studied
Chronic Prupritus Induced By Chemical Injuries
ICD-10 code
L24; L29
ICD-10 code description
Irritant contact dermatitis; Pruritus
Primary outcomes
1
Description
pruritus sevsrity
Timepoint
at the bigging off intervention,at the end of intervention
Method of measurement
standard questionaries
2
Description
pruritus distribion
Timepoint
at the bigging off intervention,at the end of intervention
Method of measurement
standard questionaries
Secondary outcomes
1
Description
pruritus frequency
Timepoint
at the bigging off intervention,at the end of intervention
Method of measurement
standard questionaries
2
Description
pruritus period
Timepoint
at the bigging off intervention,at the end of intervention
Method of measurement
standard questionaries
3
Description
quality of sleeping
Timepoint
at the bigging off intervention,at the end of intervention
Method of measurement
standard questionaries
Intervention groups
1
Description
Topical naloxan 2% formulationintervention group: 35 person will recive topical naloxan formulation, two times a day (in the morning and evening) for 4 weeks. At the begining of the study, standard questionaris will fill by the pationt and at the end of the study again to evaluate the effects of drug.
Category
Treatment - Drugs
2
Description
Control group: 35 person will recive topical palacebo formulation, two times a day (in the morning and evening) for 4 weeks. at the begining of the study,standard questionaris will fill by the pationt and at the end of the study again to evaluate the effects of drug.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Clinic of Baghiyatallah Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Baghiyatallah University
Full name of responsible person
Dr. Yunes Panahi
Street address
Baghiyatallah University, Molla sadra street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baghiyatallah University
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
Research Center of Baghiyatallah University
Full name of responsible person
Yunes Panahi
Position
PhD of clinical pharmacy
Other areas of specialty/work
Street address
Baghiyatallah University, Mollasadra street
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
Research Center of Baghiyatallah University
Full name of responsible person
Yunes Panahi
Position
PhD of clinical pharmacy
Other areas of specialty/work
Street address
Baghiyatallah University, mollasadra street
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)