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Comparison of Laser Treatment and Tacrolimus Ointment with Tacrolimus Ointment Alone for Treating Aquired Dermal Macular Hyperpigmentation

Comparative efficacy of Q switched NdYAG laser with 0.1 percent Tacrolimus ointment versus 0.1 percent Tacrolimus ointment alone in the treatment of Acquired Dermal Macular Hyperpigmentation A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/093876
Enrollment
42
Registered
2025-08-29
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Health Condition 1: L814- Other melanin hyperpigmentation

Interventions

Intervention1: Combination of Q switched Nd-YAG laser with 0.1% Tacrolimus ointment: patients will be given 4 sessions of QS NdYAG laser at 4 weeks interval along with tacrolimus ointment Control Inte

Sponsors

Dr Rashmi Sarkar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All adults in the age group of 18 years and above with clinically and histologically confirmed cases of ADMH affecting the face and/or neck, with stable disease (no new lesions or increase in size of older lesions in the past 6 months) will be included.

Exclusion criteria

Exclusion criteria: 1. Pregnant or Lactating females 2. Patient having active local infection 3. Patients having history of photosensitivity 4. Patients having keloid and keloidal tendencies

Design outcomes

Primary

MeasureTime frame
Proportion of patients in each treatment group who achieve more than 50 percent improvement according to the Physician Global Assessment Mean change in DPASI score in both the groups at 18 weeks from baseline. Timepoint: 18 wks

Secondary

MeasureTime frame
Mean improvement in patient satisfaction score in both the groups.Timepoint: 18 wks;Proportion of patients in each treatment group having improvement in quality of life, according to DLQI.Timepoint: 18 wks;Proportion of patients in each treatment group experiencing adverse effects during the treatment period.Timepoint: 18 wks

Countries

India

Contacts

Public ContactDivya Das

Lady Hardinge Medical College

rashmisarkar@gmail.com9818244340

Outcome results

None listed

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