Comparison Of Efficacy Of Combination Of TAM Formula Vs Kligman Formula For Melasma.
Comparison Of The Efficacy Of Combination Of TAM Formula Versus Kligman Formula For Melasma At Tertiary Care Hospital,Karachi.
1 other identifier
interventional
122
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2022
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedFirst Submitted
Initial submission to the registry
March 22, 2023
CompletedFirst Posted
Study publicly available on registry
August 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2023
CompletedAugust 28, 2023
August 1, 2023
4 months
March 22, 2023
August 25, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Efficacy will be assesed upto 2 months.
Study Arms (2)
Group A TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C)
EXPERIMENTALGroup B Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%)
EXPERIMENTALInterventions
TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C)
Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%)
Eligibility Criteria
You may qualify if:
- Patients between 25-65 years of age, either gender having melasma for over one month will be included in the study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
JPMC
Karachi, Sindh, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 22, 2023
First Posted
August 28, 2023
Study Start
August 1, 2022
Primary Completion
December 1, 2022
Study Completion
August 30, 2023
Last Updated
August 28, 2023
Record last verified: 2023-08