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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06013540
Recruitment Status : Active, not recruiting
First Posted : August 28, 2023
Last Update Posted : August 28, 2023
Sponsor:
Information provided by (Responsible Party):
Dr Khadijah Asadullah, Jinnah Postgraduate Medical Centre

Study Description
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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.

Condition or disease Intervention/treatment Phase
Melasma 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%) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Of The Efficacy Of Combination Of TAM Formula Versus Kligman Formula For Melasma At Tertiary Care Hospital,Karachi.
Actual Study Start Date : August 1, 2022
Actual Primary Completion Date : December 1, 2022
Estimated Study Completion Date : August 30, 2023

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Arms and Interventions
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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%)


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06013540


Locations
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Pakistan
JPMC
Karachi, Sindh, Pakistan
Sponsors and Collaborators
Jinnah Postgraduate Medical Centre
More Information
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Responsible Party: Dr Khadijah Asadullah, Principal Investigator, Jinnah Postgraduate Medical Centre
ClinicalTrials.gov Identifier: NCT06013540    
Other Study ID Numbers: NO.F2-81/2022-GENL/255/JPMC
First Posted: August 28, 2023    Key Record Dates
Last Update Posted: August 28, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Fluocinolone Acetonide
Tretinoin
Hydroquinone
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
 Protective Agents
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Radiation-Protective Agents