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NCT06013540 Clinical Trial

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

Melasma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06013540
Other study ID # NO.F2-81/2022-GENL/255/JPMC
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date August 1, 2022
Est. completion date August 30, 2023

Study information
Verified date August 2023
Source Jinnah Postgraduate Medical Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 122
Est. completion date August 30, 2023
Est. primary completion date December 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Pakistan JPMC Karachi Sindh

Sponsors (1)
Lead Sponsor Collaborator
Jinnah Postgraduate Medical Centre

Country where clinical trial is conducted

Pakistan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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.
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