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The goal of this clinical trial is to learn if the drug New Trio Combination (0.1% isobutylamido-thiazolyl-resorcinol, 0.1% retinoic acid and 0.1% dexamethasone) works to treat melasma. It will also learn about the safety of drug. This drug lowers the pigmentation severity by measuring modified Melasma Area and Severity Index (mMASI) reduction by up to 50%. The possible side effects of this drug are erythema and burning. We will compare this drug to kligman's formula (5% hydroquinon, 0.1% retinoic acid and 0.1% dexamethasone) to see if New Trio Combination works to treat melasma patients. All subjects will be divided in two groups. Group 1 will receive New trio combination (NT) and group 2 will receive Kligman's formula (KG), once daily (night time application) for 3 months. Patients will be called for follow up at 4, 8 and 12 weeks.
A total of 56 patients fulfilling the inclusion criteria are enrolled in the study. Efficacy of New Trio Combination versus Kligman's Formula will be measured in all selected patients suffering from melasma by estimating improvement in the modified MASI score and MELASQoL at each follow up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group: Group A | Experimental | Group A will receive New trio combination (NT) once daily |
|
| Control Group: Group B | Active Comparator | Group B will receive Kligman's formula (KG), once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New trio combination | Drug | New trio combination is a drug containing 0.1% isobutylamido-thiazolyl-resorcinol, 0.1% retinoic acid and 0.1% dexamethasone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Melasma Quality of Life (MELASQoL) | Melasma Quality of Life Scale (MELASQoL) will be used to assess the burden of melasma on patient's quality of life. | Responses will be assessed at baseline, 4 weeks, 8 weeks, and 12 weeks |
| modified Melasma Area and Severity Index (mMASI) | Melasma severity will be assessed by modified Melasma Area and Severity Index (mMASI). | Melasma severity over the course of 12 weeks of treatment, with responses assessed at baseline, 4 weeks, 8 weeks, and 12 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
Females
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Meshaal Azhar | Ghurki Trust Teaching Hospital | Principal Investigator |
| Prof. Dr. Haroon Nabi | Lahore Medical and Dental College | Study Director |
| Dr Aliza Hamadani | Lahore Medical and Dental College | Study Chair |
| Dr. Iram Kausar | Ghurki Trust Teaching Hospital | Study Chair |
| Dr. Ayesha Asad Chattha | Ghurki Trust Teaching Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghurki Trust Teaching Hospital | Lahore | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30422338 | Background | Kwon SH, Na JI, Choi JY, Park KC. Melasma: Updates and perspectives. Exp Dermatol. 2019 Jun;28(6):704-708. doi: 10.1111/exd.13844. Epub 2018 Dec 21. | |
| 31502392 | Background | Banavase Channakeshavaiah R, Andanooru Chandrappa NK. Topical metformin in the treatment of melasma: A preliminary clinical trial. J Cosmet Dermatol. 2020 May;19(5):1161-1164. doi: 10.1111/jocd.13145. Epub 2019 Sep 10. |
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| ID | Term |
|---|---|
| D008548 | Melanosis |
| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D019908 | Proto-Oncogene Proteins c-raf |
| ID | Term |
|---|---|
| D048490 | raf Kinases |
| D020930 | MAP Kinase Kinase Kinases |
| D017346 | Protein Serine-Threonine Kinases |
| D011494 | Protein Kinases |
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| Kligman's formula (trio) | Drug | Kligman's formula (trio) is a drug containing 5% hydroquinone, 0.1% retinoic acid and 0.1% dexamethason |
|
| Background | Shokier DA, Mohamed HF, Badria FA. Is Topical Metformin Effective in Treatment of Melasma? The Egyptian Journal of Hospital Medicine. 2023 Jan 1;90(1):1407-12. |
| 37620285 | Background | Bertold C, Fontas E, Singh T, Gastaut N, Ruitort S, Wehrlen Pugliese S, Passeron T. Efficacy and safety of a novel triple combination cream compared to Kligman's trio for melasma: A 24-week double-blind prospective randomized controlled trial. J Eur Acad Dermatol Venereol. 2023 Dec;37(12):2601-2607. doi: 10.1111/jdv.19455. Epub 2023 Sep 4. |
| D017853 |
| Phosphotransferases (Alcohol Group Acceptor) |
| D010770 | Phosphotransferases |
| D014166 | Transferases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D047908 | Intracellular Signaling Peptides and Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011518 | Proto-Oncogene Proteins |
| D015513 | Oncogene Proteins |
| D009363 | Neoplasm Proteins |