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CTRI Number  CTRI/2018/04/013522 [Registered on: 27/04/2018] Trial Registered Prospectively
Last Modified On: 04/12/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study on depression self esteem body image and quality of life in acne patients  
Scientific Title of Study   A Cross-Sectional Study Of Depression, Self Esteem, Body Image Disturbances And Quality Of Life In Patients With Acne Scars 
Trial Acronym  Ac 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neena Sawant  
Designation  Additional professor department of psychiatry at Seth GSMC KEM hospital  
Affiliation  Seth GSMC KEM hospital parel 
Address  Dept of Psychiatry Seth GSMC and KEM Hospital Acharya Donde Marg Patel Mumbai 400012

Mumbai (Suburban)
MAHARASHTRA
400012
India 
Phone  9930583713  
Fax    
Email  drneenas@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Neena Sawant  
Designation  Additional professor department of psychiatry at Seth GSMC KEM hospital  
Affiliation  Seth GSMC KEM hospital parel 
Address  Dept of Psychiatry Seth GSMC and KEM Hospital Acharya Donde Marg Patel Mumbai 400012

Mumbai (Suburban)
MAHARASHTRA
400012
India 
Phone  9930583713  
Fax    
Email  drneenas@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  sachin mahajan 
Designation  1st year MD resident in department of psychiatry at Seth GSMC KEM hospital  
Affiliation  Seth GSMC KEM hospital parel 
Address  Dept of Psychiatry Seth GSMC and KEM Hospital Acharya Donde Marg Patel Mumbai 400012

Mumbai (Suburban)
MAHARASHTRA
400012
India 
Phone  7387733976  
Fax    
Email  drsachinmahajan30@gmail.com  
 
Source of Monetary or Material Support  
Seth GSMC KEM hospital acharya donde marg, Parel  
 
Primary Sponsor  
Name  Seth GSMC KEM hospital Parel 
Address  Seth GSMC KEM hospital Acharya donde road Parel Mumbai 
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 Neena Sawant  Seth GSMC KEM hospital Parel  dermatotlogy opd no. 17,18 old kem building ground floor Seth GSMC and KEM Hospital
Mumbai (Suburban)
MAHARASHTRA 
9930583713

drneenas@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee II Seth GSMC KEM hospital Parel  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  All patients having acne scarring but no active acne,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1.All the patients clinically diagnosed as having acne scar diagnosed by the dermatologist
as per Acne Qualitative scarring grading system & All grades of acne scar
will be includedin the study
2.Age above 18 years
3.Those who willing to participate and give their consent for study 
 
ExclusionCriteria 
Details  1.Patients with active acne.
2.Patients of acne scar with co morbid skin conditions like Psoriasis, Lichen planus ,eczema etc
3. Acne patients with known history of mental illnesses and disabilities that can affect their mental state
4.Acne patients with chronic medical or surgical conditions
5.Language difficulty to understand 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Becks depression inventory for depression
Body image concern inventory for body dysmorphic concern
Rosenberg self esteem scale for level of Esteem
Dermatology quality of life index for effect of acne scarring on quality of life  
Becks depression inventory score 2weeks
Body image concern inventory scoreis 1week
Rosenberg self esteem scale is 1week
Dermatology quality of life indexis 1week 
 
Secondary Outcome  
Outcome  TimePoints 
to study association of depression on quality of life in acne scar patients
association of depression on self esteem in acne scar patients
association of depression on body image in acne scar patients  
association of depression on quality of life in acne scar patients 2week
association of depression on self esteem in acne scar patients 2week
association of depression on body image in acne scar patients 2weeks 
 
Target Sample Size   Total Sample Size="81"
Sample Size from India="81" 
Final Enrollment numbers achieved (Total)= "81"
Final Enrollment numbers achieved (India)="81" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/05/2018 
Date of Study Completion (India) 30/07/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Not yet  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

This study was designed to evaluate the prevalence of depression, severity of depression, body image disturbances, self- esteem and quality of life in patients of acne scarring.It also aimed to study the correlation of depression with self- esteem, body image disturbances and quality of life in these patients.

The following conclusions were drawn from the study –

1.     The mean age of the patients was 24.17 + 3.76 years with their ages ranging from 18-30 years.

2.     In our study, females (53.08%) slightly predominated as compared to males.(46.91%)

3.     In our study, we found that nearly 73 patients (90.12%) were single whereas only 8(9.87%) of the patients were married. This could be due to the fact that presentation of acne vulgaris is in the adolescent age group.

4.     On assessing the study population for educational level, 3 (3.70%) of the patients had completed secondary school, 24 (29.62%) of them had completed higher secondary school, and nearly 54 (66.65%) had completed a graduate / post-graduate or professional course. None of the patients in our study sample were illiterate.

5.     In our study more than 50% (66.67%) of our patients were working as compared to 32% who were unemployed.

6.     On analyzing the family income, we found that 53 (65.43%) of the patients had a monthly family income less than Rs. 12,019, and about 28 (34.56%) had an income up to Rs. 32,049.

7.     Most of our patients belonged to lower class (26%) and lower middle class (59%) whereas only 14.8% were from upper middle class.

8.     In our study we found the mean duration of acne to be 6.03 ± 2.912 years, whereas the mean duration of acne scar was 2.88 + 1.29 years.

9.     In our study, 37(45.67%) patients had grade 1 acne scars, 39 (48.14%) patients had grade 2 acne scars .Only 5(6.17%) patients had grade 3 scars.

10.   When our patients were assessed on morphological acne scar grading then nearly 45 % patients had box scars or rolling scars each respectively, ice pick scarring was seen in only 2 patients whereas hypertrophic scarring was seen in 5 patients.

11.   60% patients had less than 50 acne scars whereas 40 % patients had >50 acne scars on their faces.

12.   When our patients were assessed for the site of involvement of acne scars then all patients had facial involvement with 24 patients also having other areas involved such as back, arms, chest and shoulders.

13.    In our study all our patients had already sought some sort of pharmacological treatment which included topical antibiotics, steroids as well as chemical peels for acne. 24 (29.62%) patients had also undergone surgical intervention for the same which included dermabrasion, skin microneedling, dermal fillers and subcision. Around 38(46.91%) patients also sought ayurvedic remedies for initial acne as well as the scars. In India Ayurveda is followed & hence patients do seek this treatment option along with herbal or home remedies for improvement.

14.   When all the patients were assessed on the BDI to find the prevalence of depression we found   that the total  mean BDI score was 16.81 + 9.708. Thus, more than 1/3rd of our patients were suffering from depressive symptoms which were undiagnosed.  On assessing severity of depression as per BDI, clinical depression was reported in total 31(38.27%) patients of whom 9 (11.11%) patients had borderline clinical depression, 15 had moderate depression & 7 patients had severe depression.  36 patients reported mild mood disturbances which did not classify for diagnosis of depression while14 patients had normal mood.

15.   When all our patients were assessed for association between severity of depression as per BDI acne scar grading as per qualitative acne scar grading system we found that only 2 patients with borderline clinical depression had grade 3 scarring whereas 7 patients had grade 1scarring. 11patients of moderate depression had grade 1 scarring whereas 4 had grade 2 scarring. 4 patients with severe depression had grade 1 & 3 patients had grade 2 scarring respectively.   Majority of our patients had grade 1 / grade 2 scarring only.

16.   We also found that out of 31 patients who were clinically depressed as per BDI , 14(17.22%) patients had acne scars more than 50 and 17(20.98%) patients had acne scars less than 50.

17.   When the BICI was applied to study the prevalence of body image disturbances in our patients then, 5(6.17%) patients had a score more than 72 which was the cut off score. The total mean BICI score was   46.60 + 15.81.

18.   When we studied for self esteem in our sample then all our patients had average self high self esteem in our sample. The total  mean RSES score was 20.30 + 3.90.

19.   When all patients were assessed for impact of acne on quality of life all reported a very large effect with total mean DLQI score 16.09 + 4.04.

20.   On analyzing the study population for correlation of depression as per total BDI score with self esteem (total RSES score), body image (total BICI score), and quality of life (total DLQI Score )  we found a negative correlation between depression & self esteem ( r = -0.3626,p= 0.0009) , positive correlation between depression & body image concern(r=0.4537,p=0.0001),negative correlation between depression & quality of life(r =-0.7204,p=0.0001) .This shows that  due to depression there was lower self esteem , more body image concern and impaired  quality of life.

 
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