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CTRI Number  CTRI/2025/08/093876 [Registered on: 29/08/2025] Trial Registered Prospectively
Last Modified On: 28/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Other (Specify) [Nd YAG Laser]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of Laser Treatment and Tacrolimus Ointment with Tacrolimus Ointment Alone for Treating Aquired Dermal Macular Hyperpigmentation 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Divya Das 
Designation  post graduate resident 
Affiliation  Lady Hardinge Medical College 
Address  Department of Dermatology, Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, Lady Hardinge Medical College, DIZ Area, Connaught Place, New Delhi

Central
DELHI
110001
India 
Phone  9650115977  
Fax    
Email  das.divya123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rashmi Sarkar 
Designation  Director Professor  
Affiliation  Lady Hardinge Medical College 
Address  Department of Dermatology, Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, Lady Hardinge Medical College, DIZ Area, Connaught Place, New Delhi

Central
DELHI
110001
India 
Phone  9818244340  
Fax    
Email  rashmisarkar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Divya Das 
Designation  post graduate resident 
Affiliation  Lady Hardinge Medical College 
Address  Department of Dermatology, Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, Lady Hardinge Medical College, DIZ Area, Connaught Place, New Delhi

Central
DELHI
110001
India 
Phone  9650115977  
Fax    
Email  das.divya123@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Rashmi Sarkar 
Address  Department of Dermatology, Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, Lady Hardinge Medical College, DIZ Area, Connaught Place, New Delhi, pincode 110001, INDIA 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Divya Das  Lady Hardinge Medical College  Department of Dermatology, Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, Lady Hardinge Medical College, DIZ Area, Connaught Place, New Delhi
Central
DELHI 		 09650115977

das.divya123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, LHMC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L814||Other melanin hyperpigmentation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.1% tacrolimus ointment  patients will be advised to apply 0.1% tacrolimus ointment twice a day for 16 weeks. 
Intervention  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  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  1. Pregnant or Lactating females
2. Patient having active local infection
3. Patients having history of photosensitivity
4. Patients having keloid and keloidal tendencies
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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.
 		 18 wks 
 
Secondary Outcome  
Outcome  TimePoints 
Mean improvement in patient satisfaction score in both the groups.  18 wks 
Proportion of patients in each treatment group having improvement in quality of life, according to DLQI.  18 wks 
Proportion of patients in each treatment group experiencing adverse effects during the treatment period.  18 wks 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This protocol outlines a randomized controlled trial to compare the effectiveness of two treatments for Acquired Dermal Macular Hyperpigmentation (ADMH). The study aims to determine if a combination therapy of Q-switched Nd-YAG laser with 0.1% tacrolimus ointment is more effective than using 0.1% tacrolimus ointment alone. The primary objective is to compare changes in the Dermal Pigmentation Area and Severity Score (DPASI) and Physician’s Global Assessment. Secondary objectives include assessing patient satisfaction, quality of life using the Dermatology Life Quality Index (DLQI), and monitoring adverse effects.

The study is an open-label, randomized controlled trial involving 42 adult participants with a confirmed diagnosis of stable ADMH. The participants will be randomly allocated into two groups. Group A will receive four sessions of Q-switched Nd-YAG laser at four-week intervals, in addition to applying 0.1% tacrolimus ointment twice daily. Group B will apply 0.1% tacrolimus ointment twice daily for 16 weeks. Both groups will also use broad-spectrum sunscreen.

Evaluations will be conducted at baseline, week eight, and week 18. Baseline assessments include detailed history, examination, photographs, and calculation of the DPASI and DLQI scores. Following the treatment, improvement will be assessed using DPASI scores, clinical photographs, and patient satisfaction scores. Data will be recorded and statistically analyzed using chi-square tests, with a p-value less than 0.05 considered significant. Ethical clearance will be obtained, and all participants will provide informed, written consent. 
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