Comparison Of Efficacy Of Combination Of TAM Formula Vs Kligman Formula For Melasma.

Study Overview
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Brief Summary
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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.

Official Title
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Comparison Of The Efficacy Of Combination Of TAM Formula Versus Kligman Formula For Melasma At Tertiary Care Hospital,Karachi.

Conditions
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Melasma

Intervention / Treatment
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* Combination Product: TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C)
* Combination Product: Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C)<br> | Combination Product: TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C)<br>* TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C)<br>|
| Experimental: Group B Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%)<br> | Combination Product: Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%)<br>* Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |