Comparison of the Efficacy of topical isoniazid versus placebo in the treatment of patients with melasma in a randomized double-blind clinical trial
Design
The study is a double-blind,randomized clinical trial with control group and parallel group design
Settings and conduct
This is a randomized double-blind clinical trial study. 20 patients with age of
between 20 and 60 years old with diagnosed melasma attending dermatology clinic in Afzalipour Hospital in Kerman enroll the study. Patients are allocated to 2 groups (intervention and control) . intervention group will recieve isonicotinic acid hydrazide 10% and control group will recieve cold cream.
Participants/Inclusion and exclusion criteria
The inclusion criteria include patients with diagnosed melasma with age of between 20 and 60 years old. The exclusion criteria include Other topical medication users for melasma in the last four weeks, Kubner-positive diseases such as vitiligo ,Lactation and pregnancy,Not consent to medical photography.
Intervention groups
patients in intervention group recieve isonicotinic acid hydrazide 10% by Exir factory (topical, once daily for 3months) and control group recieve cold cream by Gol daru factory (topical, once daily for 3months).
Main outcome variables
Melanin content, Erythema content, Local complications, Systemic complications, Efficacy percentage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211125053175N1
Registration date:2022-01-29, 1400/11/09
Registration timing:prospective
Last update:2022-01-29, 1400/11/09
Update count:0
Registration date
2022-01-29, 1400/11/09
Registrant information
Name
Zahra Mahmoudi Saleh abad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 8000
Email address
minamh1992@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Efficacy of topical isoniazid versus placebo in the treatment of patients with melasma in a randomized double-blind clinical trial
Public title
Evaluating effectiveness of therapy with topical isoniazid in melasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with minimum age 20 years old to maximum 60 years old
Patients with diagnosed melasma
Exclusion criteria:
Other topical medication users for melasma in the last four weeks
Kubner-positive diseases such as vitiligo
Lactation and pregnancy
Not consent to medical photography
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, a list of random numbers was created using Excel software that determined the patients in treatment groups. In this method, the presence of patients in groups was based on the inclusion in the study after obtaining informed consent. In this study, opaque sealed plates were used to conceal random allocation, so that it is not possible to guess the allocation of each patient to the treatment group until the envelope is opened.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind study for patients and data analyzor . both drugs were kept in identical plastic containers,so the evaluating physician and patient didn't know about their containings.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical sciences
Street address
Ebne Sina Ave,Tahmasb Abad Blvd.
City
Kerman
Province
Kerman
Postal code
761614111
Approval date
2021-10-25, 1400/08/03
Ethics committee reference number
IR.KMU.AH.REC.1400.169
Health conditions studied
1
Description of health condition studied
melasma
ICD-10 code
L81.4
ICD-10 code description
Other melanin hyperpigmentation
Primary outcomes
1
Description
Melanin content
Timepoint
At the begining of the study (before intervention) and 4, 8 and12 weeks after intervention
Method of measurement
According to Quantitative measurement of erythema and pigmentation of the patient's skin by Swiss made Dermocatch device
2
Description
Efficacy
Timepoint
Percentage change in melanin content before intervention and 12 weeks after intervention.
Method of measurement
Quantitative measurement of pigmentation of the patient's skin by Swiss made Dermocatch device.
3
Description
Erythema content
Timepoint
At the begining of the study (before intervention) and 4, 8 and12 weeks after intervention
Method of measurement
Using Quantitative measurement of erythema and pigmentation of the patient's skin by Swiss made Dermocatch device
Secondary outcomes
1
Description
Erythema
Timepoint
At the begining of the study (before intervention) and 4, 8 and12 weeks after intervention
Method of measurement
By physical examination and classification of the complications severity into mild, moderate and severe
2
Description
Scaling
Timepoint
At the begining of the study (before intervention) and 4, 8 and12 weeks after intervention
Method of measurement
By physical examination and classification of the complications severity into mild, moderate and severe
3
Description
Burning sensation
Timepoint
At the begining of the study (before intervention) and 4, 8 and12 weeks after intervention
Method of measurement
By physical examination and classification of the complications severity into mild, moderate and severe
4
Description
Increased liver enzymes
Timepoint
At the begining of the study (before intervention) and 12 weeks after intervention
Method of measurement
Based on blood test findings
Intervention groups
1
Description
Intervention group:Isonicotinic acid hydrazide cream 10%. How to use: Topical use, once daily. Duration of treatment: 12 weeks. Manufacturing factory: Exir, Iran.
Category
Treatment - Drugs
2
Description
Control group: Intervention group: Cold cream. How to use: Topical use, every night. Duration of treatment: 12 weeks. Manufacturing factory:Gol daroo Pharmaceutical Factory.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
Rezvan Amiri
Street address
Imam Highway, Afzalipour Hospital
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8328
Email
rezvanamiri1358@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhty
Street address
Ebne Sina Avenue, Jahad Blvd
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
minamh1992@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Rezvan Amiri
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Imam Highway, Afzalipour Hospital
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8328
Email
rezvanamiri1358@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Rezvan Amiri
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Imam Highway, Afzalipour Hospital
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8328
Email
rezvanamiri1358@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Rezvan Amiri
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Imam Highway, Afzalipour Hospital
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8328
Email
rezvanamiri1358@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available