Comparing the combination of oral mycophenolate mofetil and topical tacrolimus with topical tacrolimus monotherapy in acquired dermal macular hyperpigmentation

A randomized controlled trial comparing the combination of oral mycophenolate mofetil and topical tacrolimus with topical tacrolimus monotherapy in acquired dermal macular hyperpigmentation

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/04/032892

Enrollment

Registered

2021-04-16

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L819- Disorder of pigmentation, unspecified

Interventions

Intervention1: Mycophenolate Mofetil and tacrolimus: Group 1- Patients treated with combination of oral MMF and topical tacrolimus (0.1%) ointment. MMF shall be started at a dose of 500 mg twice a day

Eligibility

Inclusion criteria

Inclusion criteria: Patients with a diagnosis of ADMH as follows. 21 1. Clinical â?? Hyperpigmented, non-scaly, macules and patches, either discrete or coalescing to form diffuse, blotchy, reticular or follicular patterns (must involve face and/or neck, may involve other body parts concomitantly) 2. Histopathological â?? An ongoing interface dermatitis with prominent melanin incontinence 3. Dermatoscopy â?? Presence of dots and globules. 4. An absent clinically apparent inflammatory phase prior to the appearance of the hyperpigmented patches. • Age >18 years. • Consenting for inclusion in the study

Exclusion criteria

Exclusion criteria: Age • Patients with gastric and/or hepatic abnormalities. • Patients with known hemotological disease • Pateints with renal disease. • Known hypersensitivity to drug. • Clinically cured/ persistent malignancy • Active infection or immunodeficiency. • Pregnant or lactating women.

Design outcomes

Primary

Measure	Time frame
Primary outcome measure a. Percentage reduction in DPASI from baseline, at week 24 and 36 in the two groups b. Frequency and severity of adverse effects in the two groupsTimepoint: 9 months	—

Secondary

Measure	Time frame
Secondary outcome measures a. Percentage improvement in PA scores at week 24 and 36 in the two groups. b. Proportion of patients who fail treatment (defined as a patient showing no response or worsening of the disease after 8 weeks of treatment). c. Proportion of patients with decrease in grade of progression d. Number of patients discontinuing therapy due to side effects.Timepoint: 9 months	—

Countries

India

Contacts

Public ContactVinay Keshavamurthy

Post Graduate Institute of Medical Education and Research

vinay.keshavmurthy@gmail.com07087006861

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026