| CTRI Number |
CTRI/2022/10/046452 [Registered on: 13/10/2022] Trial Registered Prospectively |
| Last Modified On: |
05/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on male equivalent of polycystic ovary syndromes in male patients of acne grade 3 and 4. |
|
Scientific Title of Study
|
A cross sectional study on clinical, hormonal and metabolic parameters of male equivalent of polycystic ovary syndrome in male patients presenting with grade 3 and grade 4 acne vulgaris. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jignaben Krunal Padhiyar |
| Designation |
Associate Professor |
| Affiliation |
GCSMCH&RC |
| Address |
Left Side of Nima School, opp famous stationary, Ahmedabad
Left Side of Nima School, opp famous stationary, Ahmedabad
Ahmadabad
GUJARAT
380013
India |
| Phone |
09909966702 |
| Fax |
|
| Email |
dr.jignapadhiyar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jignaben Krunal Padhiyar |
| Designation |
Associate Professor |
| Affiliation |
GCSMCH&RC |
| Address |
Left Side of Nima School, opp famous stationary, Ahmedabad
Left Side of Nima School, opp famous stationary, Ahmedabad
Ahmadabad
GUJARAT
380013
India |
| Phone |
09909966702 |
| Fax |
|
| Email |
dr.jignapadhiyar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jignaben Krunal Padhiyar |
| Designation |
Associate Professor |
| Affiliation |
GCSMCH&RC |
| Address |
Left Side of Nima School, opp famous stationary, Ahmedabad
Left Side of Nima School, opp famous stationary, Ahmedabad
Ahmadabad
GUJARAT
380013
India |
| Phone |
09909966702 |
| Fax |
|
| Email |
dr.jignapadhiyar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian council of Medical Research |
|
|
Primary Sponsor
|
| Name |
ICMR Indian council of medical research |
| Address |
ICMR Headquartes-Delhi |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| dr jigna padhiyar |
GCSMCH&RC (Gujarat Cancer Society Medical College, Hospital and Research Centre) |
Opp DRM office, New swadesh mill compound, Naroda road, Ahmedabad-25.
Ahmadabad
GUJARAT |
09909966702
dr.jignapadhiyar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics comittee, GCSMCH&RC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L700||Acne vulgaris, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Male |
| Details |
1. Age more than equal to 18 years.
2. Male patient with acne grade 3 and 4.
3. Patient willing to sign informed consent form
|
|
| ExclusionCriteria |
| Details |
1. Age less than 18 years.
2. Female patients of all age.
3. Male patients with acne grade 1 and 2.
4. Patient not willing to sign informed consent form.
5. Patients with underlying any endocrinological abnormality except type 2 diabetes mellitus which might interfere with study findings.
6. Patients taking oral corticosteroids taking for any medical conditions which might interfere with study findings.
7. Patients taking any hormonal therapy which might interfere with study results.
8. Patients taking any protein powders and sports medicines for body building which might interfere with study findings.
9. patients with underlying haematological and psychiatric disease.
10. Patients with underlying malignancy and paraneoplastic syndrome which might interfere with study results.
11. Major medical and surgical illness in past 4 months which might interfere with laboratory parameters in the study.
12. Patient taking herbal, homeopathic or any other alternative medicines which might interfere with study results.
13. Patients with any addictions.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To estimate the hospital-based prevalence of ME-PCOS in male patients with acne grade 3 & 4.
2. To estimate the hospital-based prevalence of other cutaneous markers of ME-PCOS in male patients with acne grade 3 & 4.
3. To estimate hospital-based hormonal and metabolic derangements in male patients with acne grade 3 & 4.
|
at baseline visit: single point cross sectional study
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To determine any corelation if any, between various clinical parameters of ME-PCOS and laboratory parameters (hormonal and metabolic).
2. To determine any correlation between various clinical and laboratory parameters with the diet taken by the patients on regular bases.
|
at baseline visit - single point cross sectional study |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/11/2022 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
will be published once completed. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Research
question:
How frequent the
clinical and laboratory parameters of male equivalent of polycystic ovary
syndrome are found in male patients with acne grade 3 & 4?
Research
hypothesis:
We hypothesise that clinical and laboratory
markers of Male equivalent of polycystic ovary syndrome are common and frequent
in male patients with acne grade 3 and 4.
Summary:
Role of hormones and metabolic derangements
has been studied in female patients with acne vulgaris. At the same time, these
factors are not properly studied in male patients with acne vulgaris. Few
studies have been recently done in foreign countries which have proposed early
onset androgenic alopecia (AGA) as a marker of male equivalent of polycystic
ovary syndrome (ME-PCOS). One latest study has summarised clinical features of
ME-PCOS which also includes acne vulgaris.
We propose a research to study clinical,
hormonal, and metabolic parameters of ME-PCOS in male patients with grade -3
and 4 acne vulgaris. It will help us to identify cutaneous markers of ME-PCOS
if any. Male patients often get severe
acne vulgaris which are not responding well to standard regimen. This study
will help us to understand the probable other side of etiological factors responsible
for development of acne in males, prevalence of ME-PCOS in male patients with
acne grade 3 & 4, and cutaneous markers of ME-PCOS which are least
researched.
We are also planning to collect data on
patients daily routine diet habit. This study will help us to understand better
management plan in terms of lifestyle modification and dietary changes in male patients
with acne grade 3 and 4. It will also help us to formulate another future
research on this topic as the prevalence of this entity is not yet known and it
has been not studied adequately in India. |