A randomised controlled trial in patients of Acquired dermal macular hyperpigmentation to find out difference in efficacy of Q-switched Nd-YAG laser with topical tacrolimus (0.1%) on one half of face and neck vs topical tacrolimus (0.1%) alone on the other half.

A split-face randomised controlled trial of Q-switched Nd-YAG laser with topical tacrolimus (0.1%) vs topical tacrolimus (0.1%) alone in the treatment of Acquired dermal macular hyperpigmentation. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/076474

Enrollment

Registered

2024-11-08

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

Health Condition 1: L818- Other specified disorders of pigmentation

Interventions

Intervention1: Q-switched 1064 nm Nd YAG laser: Therapy will be given at fluence of 1.5-3.5 J/cm2, 5 Hz frequency, 5mm spot size with 2 passes at 4 weekly intervals for 5 sessions. Control Interventio

Eligibility

Inclusion criteria

Inclusion criteria: All patients who have given written informed consent and are presenting with hyperpigmented macules/patches involving face with/without involvement of neck, with histological features suggestive of Acquired Dermal Macular Hyperpigmentation spectrum will be included.

Exclusion criteria

Exclusion criteria: Patients with any photosensitive disease,pregnant and lactating women will be excluded.

Design outcomes

Primary

Measure	Time frame
To compare the response of Qs Nd-YAG laser used along with Topical tacrolimus 0.1% vs topical tacrolimus alone in acquired dermal macular hyperpigmentation by comparing the laser-treated and control halves of the face in terms of: 1. Dermal pigmentation area and severity index 2. Patient global assessment 3. Investigator global assessment.Timepoint: Baseline, 1 month, 2 months, 3 months, 4 months and 5 months from first laser session.	—

Measure

Time frame

To compare the response of Qs Nd-YAG laser used along with Topical tacrolimus 0.1% vs topical tacrolimus alone in acquired dermal macular hyperpigmentation by comparing the laser-treated and control halves of the face in terms of: 1. Dermal pigmentation area and severity index 2. Patient global assessment 3. Investigator global assessment.Timepoint: Baseline, 1 month, 2 months, 3 months, 4 months and 5 months from first laser session.

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Secondary

Measure	Time frame
To find out the incidence and extent of spontaneous re-pigmentation in patients of lichen planus pigmentosus or acquired dermal macular hyperpigmentation.Timepoint: N/A;To find out correlation of levels of CD68 and CD8 with dermoscopic grade of pigmentation.Timepoint: At baseline.;To find out dermoscopic correlation of clinical improvement.Timepoint: At 5 months from first laser session.;To estimate the number of patients having more than 75 percent improvement in pigmentation on Investigator’s global assessment.Timepoint: At 5 months from first laser session.	—

Measure

Time frame

To find out the incidence and extent of spontaneous re-pigmentation in patients of lichen planus pigmentosus or acquired dermal macular hyperpigmentation.Timepoint: N/A;To find out correlation of levels of CD68 and CD8 with dermoscopic grade of pigmentation.Timepoint: At baseline.;To find out dermoscopic correlation of clinical improvement.Timepoint: At 5 months from first laser session.;To estimate the number of patients having more than 75 percent improvement in pigmentation on Investigator’s global assessment.Timepoint: At 5 months from first laser session.

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Countries

India

Contacts

Public ContactDr Suman Patra

All India Institute of Medical Sciences, Jodhpur

patrohere@gmail.com9650450413

Outcome results

None listed

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