Efficacy of New Trio Combination for Melasma
Efficacy of New Trio Combination Versus Kligman's Formula In Treatment of Melasma
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
-
Lahore, Pakistan
- Ghurki Trust Teaching Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Female gender
- Age range: 16-60 years
Exclusion Criteria:
- Pregnant females
- Lactating mothers
- Those taking oral contraceptive pills and phenytoin
- Lost to follow up
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Intervention Group: Group A
Group A will receive New trio combination (NT) once daily
|
New trio combination is a drug containing 0.1% isobutylamido-thiazolyl-resorcinol, 0.1% retinoic acid and 0.1% dexamethasone
|
|
Aktiv komparator: Control Group: Group B
Group B will receive Kligman's formula (KG), once daily
|
Kligman's formula (trio) is a drug containing 5% hydroquinone, 0.1% retinoic acid and 0.1% dexamethason
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Melasma Quality of Life (MELASQoL)
Tidsramme: Responses will be assessed at baseline, 4 weeks, 8 weeks, and 12 weeks
|
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)
Tidsramme: Melasma severity over the course of 12 weeks of treatment, with responses assessed at baseline, 4 weeks, 8 weeks, and 12 weeks.
|
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.
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: Prof. Dr. Haroon Nabi, Lahore Medical and Dental College
- Studiestol: Dr Aliza Hamadani, Lahore Medical and Dental College
- Studiestol: Dr. Ayesha Asad Chattha, Ghurki Trust Teaching Hospital
- Studiestol: Dr. Iram Kausar, Ghurki Trust Teaching Hospital
- Ledende efterforsker: Dr. Meshaal Azhar, Ghurki Trust Teaching Hospital
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Hudsygdomme
- Pigmenteringsforstyrrelser
- Hyperpigmentering
- Hud- og bindevævssygdomme
- Melanose
- Aminosyrer, peptider og proteiner
- Proteiner
- Enzymer
- Enzymer og coenzymer
- Transferaser
- Proteinserin-threoninkinaser
- Proteinkinaser
- Phosphotransferaser (alkoholgruppe acceptor)
- Phosphotransferaser
- Intracellulære signalpeptider og proteiner
- Neoplasma -proteiner
- raf-kinaser
- MAP Kinase Kinase Kinaser
- Proto-Onkogenproteiner
- Onkogenproteiner
- Proto-Oncogene Proteiner c-raf
Andre undersøgelses-id-numre
- R-22
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .