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CTRI Number  CTRI/2023/01/049069 [Registered on: 17/01/2023] Trial Registered Prospectively
Last Modified On: 12/11/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Chemical peels]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study of comparison of efficacy of 80% Lactic acid peel with 50% Glycolic acid for the treatment of melasma 
Scientific Title of Study   A comparative study of 80% Lactic acid peel vs 50% Glycolic acid peel in the treatment of melasma 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priya Prafulla Kadu 
Designation  Senior resident 
Affiliation  Government Medical College, Akola 
Address  Department of Dermatology, venereology, and leprosy,Government Medical College, Bhandara BK, Near Ashok Vatika, Akola

Akola
MAHARASHTRA
444001
India 
Phone    
Fax    
Email  kadupriya15@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Rachana Laul 
Designation  Professor and Head of the department 
Affiliation  Government Medical College, Akola 
Address  Department of Dermatology, venereology, and leprosy,Government Medical College, Bhandara BK, Near Ashok Vatika, Akola

Akola
MAHARASHTRA
444001
India 
Phone    
Fax    
Email  rechanalaul@gmail.com  
 
Details of Contact Person
Public Query  
Name  Priya Prafulla Kadu 
Designation  Senior resident 
Affiliation  Government Medical College, Akola 
Address  Department of Dermatology, venereology, and leprosy,Government Medical College, Bhandara BK, Near Ashok Vatika, Akola


MAHARASHTRA
444001
India 
Phone    
Fax    
Email  kadupriya15@gmail.com  
 
Source of Monetary or Material Support  
Department of Dermatology, venereology & leprosy, Government Medical College, Bhandaraj BK, Near Ashok Vatika, Akola 
 
Primary Sponsor  
Name  Priya Prafulla Kadu 
Address  Department of Dermatology, venereology & leprosy, Government Medical College, Bhandaraj BK, Near Ashok Vatika, Akola 
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 
Priya Kadu  Government Medical College and Hospital Akola  Department of Dermatology, venereology and leprosy, room number 118, 1st floor, main OPD building.
Akola
MAHARASHTRA 		 8888831974

kadupriya15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government Medical College and Hospital, Akola  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 
Intervention  80% Lactic acid Peel  Application of the agent after degreasing over the affected area for 5-15mins and neutralisation with cold normal saline. The procedure to be repeated every 2 weeks. 
Comparator Agent  Glycolic acid 50% peel  Application of the agent after degreasing over the affected area for 5-10mins and neutralisation with cold normal saline. The procedure to be repeated every 2 weeks. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Clinically diagnosed cases of melasma. 
 
ExclusionCriteria 
Details  Patients on oral Isotretinoin for the past 6 months. With a history of photosensitivity. Patients with keloidal tendency, Pregnant and lactating females. Patients with an active infection at the site of treatment.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of objective change in MASI score by 80% Lactic and 50% Glycolic peels  At the baseline and at 3 months. 
 
Secondary Outcome  
Outcome  TimePoints 
Compare side effect profiles  Every 2 weeks 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/01/2023 
Date of Study Completion (India) 05/06/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kadupriya15@gmail.com].

  6. For how long will this data be available start date provided 22-06-2023 and end date provided 19-02-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

Melasma is a commonly acquired hyperpigmentation of cosmetic concern. It has a significant impact on quality of life. Glycolic acid peel has been used in the concentration ranging from 30-70% for melasma but the choice of peels for Indian skin remains limited due to concerns of post-inflammatory hyperpigmentation. Hence, it is important to explore newer treatment modalities. 80% Lactic acid peels have shown efficacy in recent studies. We want to evaluate the efficacy of 80% Lactic acid pee in the treatment of melasma.


Objectives:

1)To compare the response to treatment by an objective reduction in melasma scores for 80% lactic acid in comparison with 50% glycolic acid peel

2) To determine the side effects of lactic 80% peel and glycolic 50% peel

    STUDY DESIGN AND SETTING - Randomized single-blinded trial

    Study Site: Department of Dermatology, Venereology & Leprosy, Tertiary Care Hospital.

    Study timeline: 4 months

     Method- Sixty-two patients from the dermatology outpatient department of a tertiary care hospital in Central India with melasma diagnosed clinically were assessed for eligibility. A total of fourty patients were included in the study after informed consent. The inclusion criterion was patients with melasma between the ages of 18-50 years old. Pregnant females, lactating females, females on oral contraceptive pills, patients with pre-existing skin diseases like inflammatory dermatoses, psoriasis, and atopic dermatitis, patients with a history of drugs with photosensitizing potential or active bacterial, viral, and fungal infections, and patients with a history of keloids were excluded from the study. As per the study conducted by Sharquie et al, Lactic acid 92% peel resulted in a reduction in the Melasma Area and Severity Index (MASI) score by 79.34%, and according to the study conducted by Javahari et al, 50% Glycolic acid peel reduced the MASI score by 35.4%. Therefore, taking into consideration a 95% confidence interval and a power of 80%, the required sample size was 20 in each group as calculated by OpenEpi software. For this study, an alpha error of 0.05 was used.

Study subjects were randomly allocated into 50% Glycolic acid and 80% Lactic acid peel groups. To randomly select among the two groups, a random number generating function RANDBETWEEN() was used with a lower limit of 1 and an upper limit of 2. If 1 was generated, Glycolic acid 50 % group was allocated and if 2 was generated, Lactic acid 80% group was allocated. The study participants were blinded and informed that they had a 50% chance of being allocated to one of the two treatments and were not aware of their respective treatment groups. The investigators could not be blinded as the packaging of the peels revealed their composition and the contact time for each peel was different. The demographic details and relevant medical history were elicited including the onset, duration, site, precipitating factors, and history of melasma onset in pregnancy. Family history was also taken from all the patients and recorded. Completion of treatment was defined as patients receiving four sessions in either group. For this study, a per-protocol approach was applied for the analysis of the results. 

        A complete dermatological examination was performed. Detailed examination of the face under good illumination was conducted to assess the size of the lesion, clinical type, homogeneity, and colour of the lesion. The MASI score was calculated at the baseline and after four sessions. Photographic documentation was done at the baseline and after four sessions. The patients were primed using 4% Hydroquinone for two weeks along with sunscreen having a sun protection factor (SPF) of 30.2,3

 A cotton gauze soaked with acetone was used for degreasing. Sensitive areas of the face like lips and nasolabial folds were protected with a thin layer of petroleum jelly. Following this, peeling was done by applying 80% Lactic acid and 50% Glycolic acid peels to respective groups over the face with a cotton wool applicator dipped in peel solution to the affected areas. Contact time was three minutes at first treatment and five minutes for subsequent sessions for Glycolic acid peel. Contact time was ten minutes at the first session and 15 minutes at subsequent sessions for Lactic acid peel. The time at which untoward side effects appeared was noted and the duration of application of the chemical was kept constant at that for the next further visits for that patient. 

Neutralization was done by cleaning the face with cold normal saline. Patients were advised to avoid washing their face with soap at least for the next 24 hours, avoid sun exposure, and apply sunscreen of SPF 30 during the daytime after peeling. Side effects, if any noticed during the study, were recorded. Post-treatment MASI score was assessed 2 weeks after the last treatment session.

The categorical variables were presented in the form of numbers and percentages. Quantitative data with normal distribution were presented as their means ± standard deviation (SD), and the data with non-normal distribution as median with twenty-fifth and seventy-fifth percentiles (interquartile range). The data normality was checked by using the Shapiro-Wilk test. In the cases in which the data was not normally distributed, we used the Mann-Whitney Test. Wilcoxon signed-rank test was used for intra-group comparison. The data entry was done in Microsoft Excel spreadsheet and the final analysis was done with the use of Statistical Package for Social Sciences (SPSS) software, IBM manufacturer, Chicago, USA, version 25.0. For statistical significance, a p-value of less than 0.05 was considered statistically significant. 

 

SAMPLE SIZE: 20 in each group

SAMPLE METHOD: Convenience sampling

DURATION OF STUDY â€“ 4 months 

Patients will be enrolled for 4 months (November 2022- February 2023)

Patients will be enrolled after ethical committee approval and informed written consent from the patients

 

MATERIALS REQUIRED

80% Lactic acid peel, 50% Glycolic acid peel, cotton wool applicator, spirit, petroleum jelly, cotton gauze, acetone, digital camera, gloves, and normal saline.

 Data collection-Data collection of the patients will be done with the help of pre-determined case record format. 

Data & statistical analysis-A total of 34 patients completed the study and were included in the final analysis. Six patients were lost to follow-up (two after priming, one after one session in the glycolic acid group, and three after two sessions in the lactic acid group) and were excluded from the final analysis.

Females comprised 94% of the study population with a male-to-female ratio of 1:17. The maximum number of female patients belonged to the age group of 30-40 years. No significant difference was seen in age (years) (p-value 0.324) and disease duration (years) (p-value 0.172) between the Glycolic acid 50% and Lactic acid 80% groups (Table 1). 

Eight cases in total (23%) had a positive family history of melasma. All the patients belonged to Fitzpatrick skin phototypes III, IV, and V. Malar pattern was the most common, seen in 28 cases, followed by centrofacial type seen in six cases. None of the patients had mandibular melasma. 

No significant difference was seen in MASI at baseline (p-value 0.959) between the Glycolic acid 50% and Lactic acid 80% groups.  The median MASI at baseline and after treatment in the Glycolic acid 50 % group was 8.2 (6-12.6) and 5.4 (3.6-9.6) respectively, and in the Lactic acid 80 % group was 8.65 (5.325-14.025) at the baseline and 7.1 (3.6-11.4) after treatment respectively (Table 2). 

 On intragroup comparison, a significant decrease was seen in MASI after treatment as compared to baseline in both the groups (p-value 0.0002 for Glycolic acid 50% and 0.001 for Lactic acid 80% peel) (Table 2, Figures 2 and 3).

The median decrease in MASI in the Glycolic acid 50 % group was 2.85 (1.875-3) which was significantly higher as compared to the Lactic acid 80 % group which was 1.8 (1.125-2.4) (p-value 0.009) (Table 2, figure 4).

The side effects noted during Glycolic acid peel treatment were transient erythema, frosting, and post-inflammatory hyperpigmentation and were found in only four cases. The study participants treated with Lactic acid peel did not report any adverse effects (Table 3). The difference between the side effects, however, was not statistically significant (p-value  0.105).

 

Ethical Declaration-Study was only after IEC/University approval. It was performed as per ICMR guidelines. All data will be kept confidential.

Financial disclosure-None to be declared.

Conflict of interest-None.

 

 
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