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
   Response - Informed Consent Form
   Response - Clinical Study Report
   Response -  Analytic Code
   
   
3. Who will be able to view these files?
   Response - Anyone
   


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


5. By what mechanism will data be made available?
   Response - Data are available indefinitely at (Link to be included ashneetderm@gmail.com).
   


6. For how long will this data be available start date provided 03-02-2028 and end date provided 01-01-0001?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Polycystic ovary syndrome PCOS is a common endocrine disorder affecting women of reproductive age and frequently presents with dermatological symptoms such as acne hirsutism androgenic alopecia and acanthosis nigricans. These cutaneous concerns have a major impact on appearance confidence and overall quality of life. Standard treatment for the skin manifestations of PCOS often includes combined hormonal pills to reduce androgen levels along with metformin to improve insulin resistance. Myoinositol is an emerging therapeutic option that also improves insulin sensitivity and may offer benefits in reducing androgenic symptoms with fewer side effects than hormonal therapy. However limited research has compared the effects of metformin combined with myoinositol against the established regimen of metformin combined with hormonal pills in obese PCOS patients specifically addressing skin outcomes.

This randomized controlled trial will compare the efficacy and safety of metformin plus myoinositol with metformin plus combined hormonal pills in obese women with PCOS who have moderate to severe dermatological manifestations. The study will be conducted in the Department of Dermatology at Kalinga Institute of Medical Sciences Bhubaneswar. Eighty participants will be enrolled and randomly allocated into two equal groups. One group will receive metformin 500 mg twice daily along with myoinositol 600 mg twice daily for three months. The other group will receive metformin 500 mg twice daily with a combined hormonal pill containing ethinyl estradiol and drospirenone for three treatment cycles.

Clinical severity of acne hirsutism alopecia and acanthosis nigricans will be evaluated using validated scoring tools at baseline and at three month follow up. Quality of life and patient satisfaction will also be assessed. Safety monitoring will include documentation of adverse effects and treatment tolerability in both groups. Data will be analyzed using standard statistical methods to compare changes within and between groups.

This study is expected to determine whether the combination of metformin and myoinositol provides superior improvement in dermatological symptoms and a better safety profile compared to the combination of metformin and hormonal pills. If successful this approach may offer an effective treatment alternative for obese PCOS patients who cannot tolerate hormonal therapy or prefer nonhormonal options.