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

August 25, 2023 updated by: Dr Khadijah Asadullah, Jinnah Postgraduate Medical Centre

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan
        • JPMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional 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)
Combination product: TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C)
TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C)
Experimental: Group B Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%)
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%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EFFICACY OF COMBINATION OF TAM FORMULA VERSUS KLIGMAN FORMULA IN TREATMENT OF MELASMA
Time Frame: Efficacy will be assesed upto 2 months.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinnah Postgraduate Medical Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

December 1, 2022

Study Completion (Estimated)

August 30, 2023

Study Registration Dates

First Submitted

March 22, 2023

First Submitted That Met QC Criteria

August 25, 2023

First Posted (Actual)

August 28, 2023

Study Record Updates

Last Update Posted (Actual)

August 28, 2023

Last Update Submitted That Met QC Criteria

August 25, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NO.F2-81/2022-GENL/255/JPMC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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