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

Phase 2

Active, not recruiting

• Conditions: Melasma
• Interventions: 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%)

• Registration Number: NCT06013540
• Lead Sponsor: Jinnah Postgraduate Medical Centre

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-01
• Primary Completion: 2022-12-01
• Study First Submitted: 2023-03-22
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-25
• Last Update Submitted: 2023-08-25
• Study First Posted: 2023-08-28
• Last Update Posted: 2023-08-28
• Study Completion: 2023-08-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 122

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C)	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%)	Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%)	-

Primary Outcome Measures

Name	Time	Method
EFFICACY OF COMBINATION OF TAM FORMULA VERSUS KLIGMAN FORMULA IN TREATMENT OF MELASMA	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)

Trial Locations

Locations (1)

JPMC; 🇵🇰 Karachi, Sindh, Pakistan