- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06013540
Comparison Of Efficacy Of Combination Of TAM Formula Vs Kligman Formula For Melasma.
August 25, 2023 updated by: Dr Khadijah Asadullah, Jinnah Postgraduate Medical Centre
Comparison Of The Efficacy Of Combination Of TAM Formula Versus Kligman Formula For Melasma At Tertiary Care Hospital,Karachi.
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.
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Interventional
Enrollment (Actual)
122
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan
- JPMC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A 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%)
|
Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Efficacy will be assesed upto 2 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2022
Primary Completion (Actual)
December 1, 2022
Study Completion (Estimated)
August 30, 2023
Study Registration Dates
First Submitted
March 22, 2023
First Submitted That Met QC Criteria
August 25, 2023
First Posted (Actual)
August 28, 2023
Study Record Updates
Last Update Posted (Actual)
August 28, 2023
Last Update Submitted That Met QC Criteria
August 25, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Hyperpigmentation
- Pigmentation Disorders
- Melanosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protective Agents
- Dermatologic Agents
- Keratolytic Agents
- Antioxidants
- Radiation-Protective Agents
- Hydroquinone
- Fluocinolone Acetonide
- Tretinoin
Other Study ID Numbers
- NO.F2-81/2022-GENL/255/JPMC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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