To compare the efficacy of transamic acid mesotherapy versus Hydroquinone, flucinolone acetonide and tretinoin
Design
Clinical trial which is parallel group, double blind, randomized, phase 3 trial.
Settings and conduct
Dermatology department PNS Shifa hospital Karachi
Participants/Inclusion and exclusion criteria
Inclusion criteria Males and females 18-55 years with facial melasma
Exclusion criteria Bleeding disorder, pregnant and lactating mothers
Intervention groups
Intervention group 1
Intradermal injection of Transamic acid into melasma areas at 2 weeks interval for 3 months.
Intervention group 2
Treatment with topical Hydroquinone, flucinolone acetonide and tretinoin cream for 12 weeks.
Main outcome variables
The degree of melasma treatment
General information
Reason for update
Acronym
Mesotherapy
IRCT registration information
IRCT registration number:IRCT20210823052264N1
Registration date:2021-09-29, 1400/07/07
Registration timing:registered_while_recruiting
Last update:2021-09-29, 1400/07/07
Update count:0
Registration date
2021-09-29, 1400/07/07
Registrant information
Name
Najia Ahmed
Name of organization / entity
PNS shifa
Country
Pakistan
Phone
+92 81 2864092
Email address
najiaomer@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-10, 1400/04/19
Expected recruitment end date
2021-11-10, 1400/08/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To Compare the efficacy of Transamic acid (TA) mesotherapy vs Hydroquinone, Flucinolone acetonide and Tretinoin for melasma
Public title
To Compare the efficacy of Transamic acid (TA) injection vs Hydroquinone, Flucinolone acetonide and Tretinoin for melasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Males and females 18-55 years with facial melasma
Exclusion criteria:
Patients who has bleeding disorders, pregnant women and lactating mothers.
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are randomly divided into two groups on simple method based on sealed envelops.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participent and data analyzer are blinded
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committe PNS shifa
Street address
Main Korangi Rd, near Kala Pul، Clifton, Karachi
City
Karachi
Postal code
(021) 48506592
Approval date
2021-07-10, 1400/04/19
Ethics committee reference number
ERC/2021/DERMA/49
Health conditions studied
1
Description of health condition studied
Melasma
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The degree of melasma treatment
Timepoint
Before treatment, at 4th, 8th and 12th week during the treatment
Method of measurement
MASI Score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In group A transamic acid is injected intradermally into melasma areas 1cm intervals every 2 weeks for 3 months.
Category
Treatment - Drugs
2
Description
Intervention group: Group B will be treated with topical Hydroquinone, Tretinoin and Fluocinolone Acetonide every night for 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
PNS Shifa Hospital
Full name of responsible person
DR Muhammad Rahim
Street address
Main Korangi Rd, near Kala Pul، Clifton, Karachi, Karachi City, Sindh
City
Karachi
Postal code
74900
Phone
+92 21 48506592
Fax
+92 21 48506592
Email
drrahimachak@gmai.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
PNS SHIFA
Full name of responsible person
Dr muhammad rahim
Street address
Main Korangi Rd, near Kala Pul، clifton karachi
City
krchi
Postal code
74900
Phone
+92 21 48506592
Fax
+92 21 48506592
Email
achakzai89@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
PNS SHIFA
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
PNS SHIFA
Full name of responsible person
Dr Muhammad Rahim
Position
Trainee
Latest degree
Bachelor
Other areas of specialty/work
Dermatology
Street address
Main Korangi Rd, near Kala Pul، Clifton
City
karachi
Province
sindh
Postal code
74900
Phone
+92 21 48506592
Fax
+92 21 48506592
Email
drrahimachak@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
pns shifs
Full name of responsible person
Dr Muhammad Rahim
Position
Trainee
Latest degree
Bachelor
Other areas of specialty/work
Dermatology
Street address
Main Korangi Rd, near Kala Pul، Clifton
City
karachi
Province
sindh
Postal code
74900
Phone
+92 21 48506592
Email
drrahimachak@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
pons shifa
Full name of responsible person
Dr Muhammad Rahim
Position
trainee
Latest degree
Bachelor
Other areas of specialty/work
Dermatology
Street address
Main Korangi Rd, near Kala Pul، Clifton,
City
karachi
Province
sindh
Postal code
74900
Phone
+92 21 48506592
Email
drrahimachak@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
primary outcome
When the data will become available and for how long
1 month after publication
To whom data/document is available
All
Under which criteria data/document could be used
Many
From where data/document is obtainable
Email Address
drrhimachak@gmail.com
What processes are involved for a request to access data/document