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

J

Jinnah Postgraduate Medical Centre

Status and phase

Active, not recruiting
Phase 2

Conditions

Melasma

Treatments

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%)

Study type

Interventional

Funder types

Other

Identifiers

NCT06013540
NO.F2-81/2022-GENL/255/JPMC

Details and patient eligibility

About

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.

Enrollment

122 patients

Sex

All

Ages

25 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

122 participants in 2 patient groups

Group A TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C)
Experimental group
Treatment:
Combination Product: 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%)
Experimental group
Treatment:
Combination Product: Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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