Ditermination of the effect of topical gabapentin on itching in patients with macular amyloidosis
Design
This study is a randomized clinical trial with parallel groups (right and left side of lesion in each patient) by using placebo control group. Sample size is 40 patients by simple sampling.
Settings and conduct
This study is performed on patients with macular amyloidosis referred to dermatology clinics of Isfahan University of Medical Sciences. Patients are enrolled after obtaining informed consent form and if they have inclusion criteria after examination. A checklist is completed for each participant including demographic data, family history, history of drug use, systemic diseases and age at onset of skin lesions, etc. Photography is done before treatment and in all of sessions in standard and fixed conditions. Each side of the lesion will be allocated to the main drug and placebo group and the other side to the gabapentin treatment group.The drug is taken twice a day and as a thin layer of topical medication. The patients will be evaluated for outcomes.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Clinical diagnosis of macular amyloidosis; Age range from 18 to 50 years; Corneal skin lesion in the back; No history of treatment in the past 6 months; Consent to attend to this study; No history of gabapentin allergy; No interference with other patient medications
Exclusion criteria: Pregnancy; Breastfeeding; Inability to take medication; Renal failure; Depression; Neurological diseases
Intervention groups
Each side of the lesion in each individual is randomly allocated to receive the main drug and the placebo, and the other side (left or right) is selected as the drug group.
Main outcome variables
Itching severity; pigmentation rate; patient satisfaction; topical side effects of drug use
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131119015455N4
Registration date:2020-01-26, 1398/11/06
Registration timing:registered_while_recruiting
Last update:2020-01-26, 1398/11/06
Update count:0
Registration date
2020-01-26, 1398/11/06
Registrant information
Name
Bahareh Abtahi-Naeini
Name of organization / entity
Skin Diseases and leishmaniasis research Center, Isfahan University of Medical Sciences, Isfahan, Ir
Country
Iran (Islamic Republic of)
Phone
+98 31 1264 2901
Email address
bahareh.abtahi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-21, 1398/08/30
Expected recruitment end date
2020-09-19, 1399/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Topical Gabapentin in Itching in Patients with Macular Amyloidosis; A pilot study
Public title
Effect of Topical Gabapentin in Itching
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical diagnosis of macular amyloidosis
Age range from 18 to 50 years
Corneal skin lesion in the back
No history of treatment in the past 6 months
Consent to attend to this study
No history of gabapentin allergy
No interference with other patient medications
Exclusion criteria:
Pregnancy
Breastfeeding
Inability to take medication
Renal failure
Depression
Neurological diseases
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
2
Corneal lesions on the back of each patient that one side is assigned to the main drug and placebo group and the other to the gabapentin treatment group.
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is performed using software to allocate each side of the lesion to the main drug and placebo group and the other side to the gabapentin treatment group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Research and Technology Deputy of Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-11-03, 1398/08/12
Ethics committee reference number
IR.MUI.MED.REC.1398.366
Health conditions studied
1
Description of health condition studied
macular amyloidosis
ICD-10 code
E85.8
ICD-10 code description
Other amyloidosis
Primary outcomes
1
Description
Itching severity
Timepoint
Before intervention and 2, 4 , 6 weeks after intervention with topical Gabapentin.
Method of measurement
12- item severity pruritus scale and 4- item itching questioner
2
Description
Pigmentation rate
Timepoint
Before intervention and 2, 4 , 6 weeks after intervention with Gabapentin
Method of measurement
Photo finder system
Secondary outcomes
1
Description
Patient satisfaction
Timepoint
Six month after treatment
Method of measurement
patient satisfaction Visual Analogue Scale score
2
Description
Topical side effects of drug use
Timepoint
Four, 8, 12 weeks and 6 months after intervention
Method of measurement
Clinical evaluation
Intervention groups
1
Description
Intervention group: One side of the lesion (left or right) on the back of each patient is randomly allocated to receive topical Gabapentin in gel based with 0.06 concentration (Temad and Farabi company) that is used as a thin layer and twice a day for 3 months.
Category
Treatment - Drugs
2
Description
Control group: The other side of the lesion (left or right) on the back of each patient is selected to receive placebo in gel based (Timad company) that is used as a thin layer and twice a day.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology clinic of Al-Zahra hospital, Isfahan
Full name of responsible person
Dr. Bahar Saffar
Street address
Department of Pathology, Al-Zahra hospital, Soffeh Boulevard, Isfahan