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
• Status: Active, not recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Melanosis
• Melasma

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.