A Phase 4 interventional study of Oral tranexamic acid + triple combination cream (fluocinolone acetonide + hydroquinone + tretinoin) and Triple combination cream (fluocinolone acetonide + hydroquinone + tretinoin) alone in Melasma and Melasma (Facial Melasma), sponsored by Combined Military Hospital Abbottabad. Not yet recruiting. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Combined Military Hospital Abbottabad · Phase 4, Interventional, and Treatment
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.
170 studies on the registry are indexed under Melanosis; 46 are open to participants now.
This study's planned enrollment of 128 is above the median of 40 across 157 interventional studies indexed under Melanosis.
Browse Melanosis studies →Combined Military Hospital Abbottabad is the lead sponsor of 25 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria: Patients with dermal melasma, pregnancy, lactation, history of thromboembolic disease, coagulation disorders, current hormonal therapy use, recent treatment for melasma, to study medications, or significant hepatic or renal disease will be excluded.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Combination Product: Oral tranexamic acid + triple combination cream (fluocinolone acetonide + hydroquinone + tretinoin)
Drug: Triple combination cream (fluocinolone acetonide + hydroquinone + tretinoin) alone
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.
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.
MASI Score
Change in Melasma Area and Severity Index (MASI) score from baseline to the end of treatment period.
Time frame: 6 months
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be made publicly available due to privacy and confidentiality considerations. Only aggregated study results may be reported or published.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Combined Military Hospital Abbottabad