Back to resultsComparison Of Efficacy Of Combination Of TAM Formula Vs Kligman Formula For Melasma.
Primary Purpose
Melasma
Status
Active
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C)
Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%)
Sponsored by
About this trial
This is an interventional treatment trial for Melasma
Eligibility Criteria
Inclusion Criteria: Patients between 25-65 years of age, either gender having melasma for over one month will be included in the study Exclusion Criteria: Pregnancy, breastfeeding, taking birth control pills or plans to become pregnant during the study History of cutaneous photosensitization, porphyria, and hypersensitivity to porphyrins or photodermatosis History of skin pathology or condition that could interfere with the evaluation or requires the use of interfering topical or systemic therapy History of uncorrected coagulation defect or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy) History of sensitivity to hydroquinone or Retin-A History of evidence of a compromised immune system or hepatitis
Sites / Locations
- JPMC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C)
Group B Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%)
Arm Description
Outcomes
Primary Outcome Measures
EFFICACY OF COMBINATION OF TAM FORMULA VERSUS KLIGMAN FORMULA IN TREATMENT OF MELASMA
Efficacy will be assessed by using Modified MASI(Melasma Area and Severity Index)In MASI scoring the "area of involvement" is calculated from 0 to 6 while the intensity and homogeneity of pigmentation are scored from 0 to 4 only. (Melasma Area Severity Index)
Secondary Outcome Measures
Full Information
NCT ID
NCT06013540
First Posted
March 22, 2023
Last Updated
August 25, 2023
Sponsor
Jinnah Postgraduate Medical Centre
1. Study Identification
Unique Protocol Identification Number
NCT06013540
Brief Title
Comparison Of Efficacy Of Combination Of TAM Formula Vs Kligman Formula For Melasma.
Official Title
Comparison Of The Efficacy Of Combination Of TAM Formula Versus Kligman Formula For Melasma At Tertiary Care Hospital,Karachi.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
August 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinnah Postgraduate Medical Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study would offer the participants about the knowledge of these formula in the treatment of melasma and help the investigators in incorporating and updating the management protocols in medical practice.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melasma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C)
Arm Type
Experimental
Arm Title
Group B Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%)
Arm Type
Experimental
Intervention Type
Combination Product
Intervention Name(s)
TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C)
Intervention Description
TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C)
Intervention Type
Combination Product
Intervention Name(s)
Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%)
Intervention Description
Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%)
Primary Outcome Measure Information:
Title
EFFICACY OF COMBINATION OF TAM FORMULA VERSUS KLIGMAN FORMULA IN TREATMENT OF MELASMA
Description
Efficacy will be assessed by using Modified MASI(Melasma Area and Severity Index)In MASI scoring the "area of involvement" is calculated from 0 to 6 while the intensity and homogeneity of pigmentation are scored from 0 to 4 only. (Melasma Area Severity Index)
Time Frame
Efficacy will be assesed upto 2 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients between 25-65 years of age, either gender having melasma for over one month will be included in the study
Exclusion Criteria:
Pregnancy, breastfeeding, taking birth control pills or plans to become pregnant during the study
History of cutaneous photosensitization, porphyria, and hypersensitivity to porphyrins or photodermatosis
History of skin pathology or condition that could interfere with the evaluation or requires the use of interfering topical or systemic therapy
History of uncorrected coagulation defect or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy)
History of sensitivity to hydroquinone or Retin-A
History of evidence of a compromised immune system or hepatitis
Facility Information:
Facility Name
JPMC
City
Karachi
State/Province
Sindh
Country
Pakistan
12. IPD Sharing Statement
Learn more about this trial
Comparison Of Efficacy Of Combination Of TAM Formula Vs Kligman Formula For Melasma.
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