Melasma, Melasma (Facial Melasma)
Conditions
Keywords
Tranexamic Acid, MASI Score, Melasma, Triple Combination Therapy
Brief summary
The data will be collected after the permission of the ethical committee of hospital. Following the enrollment, patients will be selected by lottery in the two equal groups. Group A will be administered with oral tranexamic acid and triple combination therapy whereas Group B will be treated with triple combination therapy. Strict use of sunscreens and sun protection will be promoted to all patients. Group A will administer oral tranexamic acid with the prescribed dose of the study drug along with topical application of fluocinolone acetonide, hydroquinone and tretinoin at bedtime. Group B will be treated by triple combination therapy only once a day at night. The study will continue to treatment. There will be a baseline MASI score which will be taken prior to the onset of treatment and re-evaluated at the planned follow-ups. The main outcome will be the decrease in the MASI score and the percentage of the patients who will be responding to treatment. The negative effects and recurrence in the follow-up will be considered as secondary outcomes. The structured proforma will gather data on age, gender, melasma duration, skin phototype, baseline MASI score, treatment group, follow-up MASI score, percentage improvement, adverse effects and treatment response. The principal investigator will document all the findings.
Interventions
COMBINATION_PRODUCTOral tranexamic acid + triple combination cream (fluocinolone acetonide + hydroquinone + tretinoin)
Participants will receive oral tranexamic acid in combination with topical triple combination cream (fluocinolone acetonide, hydroquinone, and tretinoin) for the treatment of melasma. The efficacy and safety of this combined therapy will be evaluated and compared with triple combination cream alone.
DRUGTriple combination cream (fluocinolone acetonide + hydroquinone + tretinoin) alone
Participants will receive topical triple combination cream containing fluocinolone acetonide, hydroquinone, and tretinoin alone as standard therapy for the treatment of melasma. Its efficacy and safety will be compared with the combination therapy including oral tranexamic acid.
Sponsors
Combined Military Hospital Abbottabad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Patients aged 18 to 50 years of either gender with clinically diagnosed epidermal or mixed melasma of at least six months duration and baseline MASI score above the predefined threshold will be included. Patients willing to comply with treatment and follow-up schedule will be enrolled. \-
Exclusion criteria
Patients with dermal melasma, pregnancy, lactation, history of thromboembolic disease, coagulation disorders, current hormonal therapy use, recent treatment for melasma, hypersensitivity to study medications, or significant hepatic or renal disease will be excluded. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MASI Score | 6 months | Change in Melasma Area and Severity Index (MASI) score from baseline to the end of treatment period. |
Contacts
CONTACTKiran Nawaz Jadoon, MBBS
STUDY_CHAIRAli Amar, MBBS, FCPS, CHPE
Combined Military Hospital Abbottabad
Outcome results
None listed