UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050940 |
|---|---|
| Receipt number | R000058063 |
| Scientific Title | A PROSPECTIVE, RANDOMIZED AND OPEN LABEL STUDY TO COMPARE EFFICACY AND SAFETY OF TOPICAL GLUTATHIONE (2%) WITH TOPICAL TRANEXAMIC ACID (3%) IN ADULT MELASMA PATIENTS |
| Date of disclosure of the study information | 2023/05/04 |
| Last modified on | 2023/04/27 00:50:24 |
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Basic information
Public title
A PROSPECTIVE, RANDOMIZED AND
OPEN LABEL STUDY TO COMPARE
EFFICACY AND SAFETY OF TOPICAL GLUTATHIONE (2%) WITH TOPICAL
TRANEXAMIC ACID (3%) IN ADULT
MELASMA PATIENTS
Acronym
TGTTAS
Scientific Title
A PROSPECTIVE, RANDOMIZED AND
OPEN LABEL STUDY TO COMPARE
EFFICACY AND SAFETY OF TOPICAL GLUTATHIONE (2%) WITH TOPICAL
TRANEXAMIC ACID (3%) IN ADULT
MELASMA PATIENTS
Scientific Title:Acronym
TGTTAS
Region
| Asia(except Japan) |
Condition
Condition
MELASMA
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of Topical Glutathione [2% gel] with Topical TA [3% gel] in adult melasma patients
To evaluate the adverse effects of both drugs
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Evaluation of efficacy of topical glutathione (2%) in comparison to topical tranexamic acid (3%) through evaluation by Modified Melasma Area Severity Index at baseline, 30, 60 and 90 days of study (mMASI) and Physician Global Assessment (PGA) scores at 30, 60 and 90 days of study
Key secondary outcomes
Evaluation of safety by documenting proportion of adverse effects in each group at 30, 60 and 90 days of study
Evaluation of quality of life by Melasma Quality of Life Index (MELASQOL) at baseline and 90 days of study
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Topical Glutathione (2%), each time - amount sufficient for thin uniform film over face, BD (Twice daily - morning and evening)
Interventions/Control_2
Topical tranexamic acid (3%), each time - amount sufficient for thin uniform film over face, BD (Twice daily - morning and evening)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Melasma patients diagnosed clinically
Study subjects between eighteen to sixty years of age, irrespective of sex, socio-economic status and duration of lesions
Key exclusion criteria
Patients refusing to give written informed consent
Hypersensitivity to test drugs
Pregnancy and lactation
Any major comorbidities
Hormonal medication 3 months prior to study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Dr Saurabh |
| Middle name | |
| Last name | Bijalwan |
Organization
GOVERNMENT MEDICAL COLLEGE AMRITSAR
Division name
PHARMACOLOGY DEPARTMENT
Zip code
143001
Address
GOVERNMENT MEDICAL COLLEGE AMRITSAR, CIRCULAR ROAD, AMRITSAR, PUNJAB, INDIA
TEL
+917895168233
sophshan93@gmail.com
Public contact
Name of contact person
| 1st name | DR SAURABH |
| Middle name | |
| Last name | BIJALWAN |
Organization
GOVERNMENT MEDICAL COLLEGE AMRITSAR
Division name
PHARMACOLOGY
Zip code
143001
Address
GOVERNMENT MEDICAL COLLEGE AMRITSAR, CIRCULAR ROAD, AMRITSAR, PUNJAB, INDIA
TEL
+917895168233
Homepage URL
SOPHSHAN93@GMAIL.COM
Sponsor or person
Institute
DEPARTMENT OF PHARMACOLOGY, GOVERNMENT MEDICAL COLLEGE AMRITSAR
Institute
Department
Personal name
Funding Source
Organization
SELF FUNDING
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
GOVERNMENT MEDICAL COLLEGE AMRITSAR
Address
GOVERNMENT MEDICAL COLLEGE AMRITSAR, CIRCULAR ROAD, AMRITSAR, PUNJAB, INDIA
Tel
1832426506
principalgmc@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
60
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 27 | Day |
Last modified on
| 2023 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058063
