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CTRI Number  CTRI/2025/08/093240 [Registered on: 19/08/2025] Trial Registered Prospectively
Last Modified On: 15/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare two different modalities in the treatment dark circle around eye 
Scientific Title of Study   Comparison of 10 percent trichloroacetic acid and 35 percent glycolic acid peel in the treatment of periorbital hyperpigmentation 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bijendra Singh 
Designation  DNB student 
Affiliation  dr baba saheb ambedker medical college and hospital 
Address  skin OPD Room no- 1004 Department of Dermatology
DR. Baba Saheb Ambedkar Hospital, Sector- 06 Rohini Delhi -85
North West
DELHI
110085
India 
Phone  9350596379  
Fax    
Email  drbijuucms@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  dr Vivek sagar 
Designation  Associate professor 
Affiliation  dr baba saheb ambedker medical college and hospital 
Address  Skin OPD Room no- 1001 Department of Dermatology
DR Baba Saheb Ambedkar hospital Sector 06 Rohini New Delhi -85
North West
DELHI
110085
India 
Phone  9210338647  
Fax    
Email  viveksagar_sagar@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  dr Vivek sagar 
Designation  Associate professor 
Affiliation  dr baba saheb ambedker medical college and hospital 
Address  Skin OPD Room no- 1001 Department of Dermatology
DR. Baba Saheb Ambedkar Hospital Sector 06 Rohini Delhi -85
North West
DELHI
110085
India 
Phone  9210338647  
Fax    
Email  viveksagar_sagar@yahoo.co.in  
 
Source of Monetary or Material Support  
Dr Baba Saheb Ambedkar medical college and hospital SECTOR 06 Rohini North west Delhi 110085 India  
 
Primary Sponsor  
Name  Dr Baba Saheb Ambedkar medical college and hospital 
Address  Sector 6 Rohini North west Delhi 110085 India 
Type of Sponsor  Government medical college 
 
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 Bijendra Singh  Dr Baba Saheb Ambedkar Medical College and hospital  Skin OPD Room no 1004 Department of Dermatology Sector 6 Rohini North west Delhi 110085 India
North West
DELHI 		 9350596379

drbijuucms@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee and Scientific Research Committee (IEC - SRC) Dr Baba Saheb Ambedkar Medical College and hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  ICD-10 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  10 % trichloroacetic acid peel   1.Patients will be made to lie down in a reclining position. A postauricular patch test will be performed on each patient 15 minutes prior to the peeling session. After the test peel, the area to be treated will be degreased with a 50% alcohol solution. 2. 10% of TCA will be applied on the right side with a cotton-tipped applicator in the periorbital areas ages(18-60) until the appearance of frosting and neutralized with normal saline after 2 minute. 3.The peeling will be done at an interval of 3 weeks on week (0,3,6,9), for a total of four sessions and followed up on 12 weeks. total duration of study over the 1 year  
Comparator Agent  35% glycolic acid peel  .Patients will be made to lie down in a reclining position. A postauricular patch test will be performed on each patient 15 minutes prior to the peeling session. After the test peel, the area to be treated will be degreased with a 50% alcohol solution. 2.35% glycolic acid will be applied on the left side with a cotton-tipped applicator in the periorbital area areas aged(18-60)year until the appearance of frosting and neutralized with normal saline after 2 minute. 3.The peeling will be done at an interval of 3 weeks on week (0,3,6,9), for a total of four sessions and followed up on 12 weeks. total duration of study the 1 year 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All patient age 18-60 years attending the outpatient department clinically diagnosed as periorbital hyperpigmentation and are willing to participate in the study after giving informed consent. 
 
ExclusionCriteria 
Details  1.Patients on topical steroid or systemic treatment for POH In the past 1 month.
2.Patients with photosensitive disorder/photosensitizing drug
3.Inflammatory dermatoses on the face
4.Patients with unilateral POH
5.Patients with history of keloid scaring
6.Pregnancy and lactation
7.Active viral/bacterial/infection on face 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of 10% trichloroacetic acid peel and 35% glycolic acid peel in administered every three weeks for four sessions in the treatment of periorbital hyperpigmentation (aged 18-60) as assessed by dermoscopic and physician’s global assessment at pre- and post-12-week follow-up.  0,3,6,9 and 12 weeks follow up 
 
Secondary Outcome  
Outcome  TimePoints 
•To compare the safety of 10% trichloroacetic peel and 35% glycolic acid peel in patients studied.
• To evaluate physician global assessment feature in clinical subtype of periorbital hyperpigmentation in patient included this study.
 		 0,3,6,9 and 12 weeks follow up 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   30/08/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 study is a randomized interventions split face study , single blinded ,parallel group, single central trail comparing the efficacy and safety of trichloroacetic acid and glycolic acid peel in the treatment of periorbital hyper pigmentation for one year duration that study should be conducted on Dr Baba Saheb Ambedkar medical college and hospital Rohini Delhi India. the primary outcome measure the efficacy of trichloroacetic acid peel vs glycolic acid peel 3 weeks for four session 0,3,6,9 weeks and follow up after 12 weeks and dermoscope picture taken pre and post treatment and the secondary  outcome will be safety and physician global assessment trichloroacetic acid peel vs glycolic acid peel in treatment of periorbital hyper pigmentation.
Inclusion criteria -All patient of age  18-60 years attending the outpatient department clinically  diagnosed as periorbital hyperpigmentation and are willing to participate in the study after giving informed consent.
Exclusion criteria-
- Patients on topical or systemic treatment for POH in the past 1 month
- Patients with photosensitive disorders/on photosensitizing drugs
- Inflammatory dermatoses on the face
- Patients with unilateral POH
- Patients with a history of keloid scarring
 Pregnancy and lactation
- Active viral/bacterial/ infection on face

METHODOLOGY

1. Patients clinically diagnosed with POH will be provided with a Patient information sheet and invited to  participate in the study
2. Written informed consent will be taken from all the patients prior to inclusion in he study
inclusion in the study.
3. Detailed demographic data and clinical history, including the onset, duration of POH, aggravating factors, treatment received, any prolonged
drug intake, cosmetic use, history of atopy, family history, and menstrual history of all the patients will be taken and recorded in a preset proforma.
4. Detailed examination of the face under good illumination will be conducted to assess the lesions, clinical type, and grade of POH.

5. Clinical photographs (without revealing identity) using standardized position from forehead to malar area and dermoscopic photographs in both polarized and nonpolarized lights will be taken at 0, 3, 6, 9, and 12 weeks.
Procedure
1. Patients will be made to lie down in a reclining position. A postauricular patch test will be performed on each patient 15 minutes prior to the peeling session. After the test peel, the area to be treated will be degreased with a 50% alcohol solution.
2. 10% of TCA will be applied on the right side with a cotton-tipped applicator in the infraorbital areas until the appearance of frosting.
3. Similarly, on the left side 35% GA will be applied, and neutralized with saline after 2 minutes.
4. After neutralising both peels with saline, patients will be asked to apply sunscreen with sun protection factor 30 on their faces before stepping out
of the hospital.
5. They will be instructed to apply sunscreen regularly.
6. The peeling will be done at an interval of 3 weeks on week 0,3,6,9, for a
total of four sessions and followed up on week 12.
7. Single blinding will be done.

Physician’s global assessment
The improvement will be evaluated by means of photographs by the
dermatologist using the following grading scale at 12 weeks of follow up.

Patient’s global assessment-
Patient assessment will be graded as poor, fair, good, and excellent at 12 weeks follow-up by the patient on a similar scale as the Physician’s Global Assessment.
Periorbital hyperpigmentation grading
The degree of improvement in periorbital pigmentation will be done by Periorbital
hyperpigmentation (POH) grading as 
0 – Skin colour comparable to other facial skin areas 1 – Faint pigmentation of infraorbital fold. 2 – Pigmentation more pronounced. 3 – Deep dark colour, all four lids involved. 4 – Grade 3 + pigmentation spreading beyond the infraorbital fold.

Dermoscopic examination
Dermoscopic examination finding Right eye Left eye
0 week 12 weeks  with following pattern 
Epidermal-
Homogeneous light brown
Cobble stone
Homogeneous light brown with
speckled
Dermal
Speckled
Globules
Cobblestone
Mixed (epidermal and dermal)
 
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