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 Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- 1.To estimate the hospital-based prevalence of ME-PCOS in male patients with acne grade 3 & 4.
Study Overview
Brief Summary
Researchquestion:
How frequent theclinical and laboratory parameters of male equivalent of polycystic ovarysyndrome are found in male patients with acne grade 3 & 4?
Researchhypothesis:
We hypothesise that clinical and laboratorymarkers of Male equivalent of polycystic ovary syndrome are common and frequentin male patients with acne grade 3 and 4.
Summary:
Role of hormones and metabolic derangementshas been studied in female patients with acne vulgaris. At the same time, thesefactors are not properly studied in male patients with acne vulgaris. Fewstudies have been recently done in foreign countries which have proposed earlyonset androgenic alopecia (AGA) as a marker of male equivalent of polycysticovary syndrome (ME-PCOS). One latest study has summarised clinical features ofME-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 -3and 4 acne vulgaris. It will help us to identify cutaneous markers of ME-PCOSif any. Male patients often get severeacne vulgaris which are not responding well to standard regimen. This studywill help us to understand the probable other side of etiological factors responsiblefor development of acne in males, prevalence of ME-PCOS in male patients withacne grade 3 & 4, and cutaneous markers of ME-PCOS which are leastresearched.
We are also planning to collect data onpatients daily routine diet habit. This study will help us to understand bettermanagement plan in terms of lifestyle modification and dietary changes in male patientswith acne grade 3 and 4. It will also help us to formulate another futureresearch on this topic as the prevalence of this entity is not yet known and ithas been not studied adequately in India.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- Male
Inclusion Criteria
- •Age more than equal to 18 years.
- •Male patient with acne grade 3 and
- •Patient willing to sign informed consent form.
Exclusion Criteria
- •Age less than 18 years.
- •Female patients of all age.
- •Male patients with acne grade 1 and
- •Patient not willing to sign informed consent form.
- •Patients with underlying any endocrinological abnormality except type 2 diabetes mellitus which might interfere with study findings.
- •Patients taking oral corticosteroids taking for any medical conditions which might interfere with study findings.
- •Patients taking any hormonal therapy which might interfere with study results.
- •Patients taking any protein powders and sports medicines for body building which might interfere with study findings.
- •patients with underlying haematological and psychiatric disease.
- •Patients with underlying malignancy and paraneoplastic syndrome which might interfere with study results.
- •Major medical and surgical illness in past 4 months which might interfere with laboratory parameters in the study.
- •Patient taking herbal, homeopathic or any other alternative medicines which might interfere with study results.
- •Patients with any addictions.
Outcomes
Primary Outcomes
1.To estimate the hospital-based prevalence of ME-PCOS in male patients with acne grade 3 & 4.
Time Frame: at baseline visit: single point cross sectional study
2. To estimate the hospital-based prevalence of other cutaneous markers of ME-PCOS in male patients with acne grade 3 & 4.
Time Frame: at baseline visit: single point cross sectional study
3. To estimate hospital-based hormonal and metabolic derangements in male patients with acne grade 3 & 4.
Time Frame: at baseline visit: single point cross sectional study
Secondary Outcomes
- 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.)