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

Sponsor

Jinnah Postgraduate Medical Centre (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06013540

Collaborator

(none)

122

Enrollment

Location

Arms

12.9

Anticipated Duration (Months)

9.4

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Aug 1, 2022

Actual Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Aug 30, 2023

Arms and Interventions

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%)

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

Primary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	JPMC	Karachi	Sindh	Pakistan

Sponsors and Collaborators

Jinnah Postgraduate Medical Centre

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Aug 28, 2023

Last Update Posted:

Aug 28, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Melanosis

Fluocinolone Acetonide

Tretinoin

Hydroquinone

Study Results

No Results Posted as of Aug 28, 2023