Melasma
Conditions
Keywords
melasma, New Trio Combination, Kligman's Formula
Brief summary
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.
Interventions
DRUGNew trio combination
New trio combination is a drug containing 0.1% isobutylamido-thiazolyl-resorcinol, 0.1% retinoic acid and 0.1% dexamethasone
DRUGKligman's formula (trio)
Kligman's formula (trio) is a drug containing 5% hydroquinone, 0.1% retinoic acid and 0.1% dexamethason
Sponsors
Ghurki Trust and Teaching Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Melasma Quality of Life (MELASQoL) | 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. |
| 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. | Melasma severity will be assessed by modified Melasma Area and Severity Index (mMASI). |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORDr. Meshaal Azhar
Ghurki Trust Teaching Hospital
STUDY_DIRECTORProf. Dr. Haroon Nabi
Lahore Medical and Dental College
STUDY_CHAIRDr Aliza Hamadani
Lahore Medical and Dental College
STUDY_CHAIRDr. Iram Kausar
Ghurki Trust Teaching Hospital
STUDY_CHAIRDr. Ayesha Asad Chattha
Ghurki Trust Teaching Hospital
Outcome results
None listed