Comparison of efficacy and safety of intra lesional tranexamic acid injection versus topical Kligman’s formula application in the treatment of macular amyloidosis
Comparison of efficacy and safety of intra lesional tranexamic acid injection versus topical Kligman’s formula application in the treatment of macular amyloidosis
Design
A double blind randomized clinical trial in 40 patients
Settings and conduct
This study will be conducted in Hazrate Rasoule Akram Hospital, Tehran, Iran. 40 macular amyloidosis patients will randomly divided to tranexamic acid (4 mg/ml intradermally)and Kligman (a tip of finger topical Kligman each night) groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age range 18 to 50 years, suffering from macular amyloidosis
Exclusion criteria: pregnant or lactating women, history of cardiovascular disease, Keloid patients, patients taking anticoagulants, any allergy to the study drugs, history of bleeding disorder, topical treatment three months before entering the study, no consent to participate in the study
Intervention groups
Tranexamic acid group: Six sessions of treatment every two weeks are given by the physician as an intra lesional tranexamic acid.
Kligman group: Apply a tip of finger topical Kligman each night for 12 weeks
Main outcome variables
Skin darkness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150529022468N5
Registration date:2019-07-30, 1398/05/08
Registration timing:registered_while_recruiting
Last update:2019-07-30, 1398/05/08
Update count:0
Registration date
2019-07-30, 1398/05/08
Registrant information
Name
Mohammadreza Ghassemi
Name of organization / entity
Iran University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 2040
Email address
ghassemi.mr@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy and safety of intra lesional tranexamic acid injection versus topical Kligman’s formula application in the treatment of macular amyloidosis
Public title
Comparison of tranexamic acid versus Kligman’s application in the treatment of macular amyloidosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 18 to 50 years
Suffering from macular amyloidosis
Exclusion criteria:
Pregnant or lactating women
History of cardiovascular disease
Keloid patients
Patients taking anticoagulants
Any allergy to the study drugs
History of bleeding disorder
Topical treatment three months before entering the study
No consent to participate in the study
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
To select patients randomly, 40 pieces of paper will be numbered from 1 to 40. For each patient one of the papers will be taken in random order. If the number is paired, the patient will be in the tranexamic acid group, and if the number is Odd in the Kligman group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will be evaluated by a physician. This physician will be blind to the grouping of patients. In addition, the data analyzer will be blind to the grouping of patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-07-02, 1398/04/11
Ethics committee reference number
IR.IUMS.FMD.REC.1398.138
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
Skin darkness
Timepoint
4, 8 and 12 weeks after start and 3 months after finishing the treatment
Method of measurement
The Visioface device, the third physician's opinion, and the patient's opinion.
Secondary outcomes
1
Description
drug side effects
Timepoint
4, 8 and 12 weeks after start and 3 months after finishing the treatment
Method of measurement
Check list
2
Description
Onset of therapeutic effect
Timepoint
4, 8 and 12 weeks after start and 3 months after finishing the treatment
Method of measurement
The Visioface device, the third physician's opinion, and the patient's opinion. The doctor's and patient opinion will be announced through the following options: 1. No response (no amelioration) 2. poor response (amelioration less than 25%) 3. average response (amelioration from 25% to 50%) 4. good response (amelioration from 50% to 75%) 5. very good response (amelioration by more than 75%)
3
Description
Continuity of drug effect
Timepoint
4, 8 and 12 weeks after start and 3 months after finishing the treatment
Method of measurement
The Visioface device, the third physician's opinion, and the patient's opinion. The doctor's and patient opinion will be announced through the following options: 1. No response: no amelioration 2. poor response: amelioration less than 25% 3. average response: amelioration from 25% to 50% 4. good response: amelioration from 50% to 75% 5. very good response: amelioration by more than 75%
Intervention groups
1
Description
Intervention group: tranexamic acid. Six sessions of treatment every two weeks are given by the physician as an intra lesional tranexamic acid. Each session, 0.1 cc of 4 mg / ml tranexamic acid will be injected interdermally with a 30-G needle and at a distance of 1 cm to an area of 10*10 cm which covers the entire lesion area.
Category
Treatment - Drugs
2
Description
Intervention group: Kligman (with hydroquinone 4.0%, tretinoin 0.05%, fluocinolone acetonide 0.01%, vit c 500mg formula). Apply a tip of finger topical Kligman on a dry and clean skin each night for 12 weeks and do not rinse at least 4 hours after application.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Dermatology of Hazrate Rasoule Akram Hospital