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

NCT ID: NCT06013540

Last Updated: 2023-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-08-30

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.

Detailed Description

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Conditions

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Melasma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C)

Group Type EXPERIMENTAL

TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C)

Intervention Type 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%)

Group Type EXPERIMENTAL

Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%)

Intervention Type COMBINATION_PRODUCT

Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%)

Interventions

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TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C)

TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C)

Intervention Type COMBINATION_PRODUCT

Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%)

Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%)

Intervention Type COMBINATION_PRODUCT

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jinnah Postgraduate Medical Centre

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr Khadijah Asadullah

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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JPMC

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id

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