Balancing Efficacy and Safety: A prospective comparative study of Prednisolone and Deflazacort in adults with Steroid Responsive Dermatoses.

Introduction Steroid responsive dermatoses such as lichen planus pemphigus vulgaris discoid lupus erythematosus and severe atopic dermatitis require systemic corticosteroids to achieve rapid disease control. Prednisolone is commonly prescribed because of strong anti inflammatory and immune suppressing actions. Long term use of Prednisolone can lead to adverse effects such as cushingoid features skin thinning acne like eruptions and disturbances in metabolism which can reduce treatment adherence and affect quality of life. Deflazacort is a corticosteroid that is structurally related to Prednisolone and has similar therapeutic action with a potentially better safety and tolerability profile. It has less impact on carbohydrate metabolism and causes less loss of calcium making it useful in long term management of chronic inflammatory skin disorders. However there is limited dermatology specific evidence comparing the clinical effectiveness and safety of Deflazacort and Prednisolone. Many published reports are isolated cases or based on non dermatology systemic diseases. Therefore there is a need for a systematic comparative study to evaluate the clinical efficacy safety and patient tolerability of Deflazacort and Prednisolone in steroid responsive dermatoses. This study aims to generate evidence that can support rational corticosteroid selection in dermatology clinical practice.

Justification Systemic corticosteroids are a key part of therapy in many steroid responsive dermatoses where topical medicines alone are not sufficient. Prednisolone is widely used but its side effects are dose and duration dependent and they limit long term safety and patient adherence. Deflazacort has been promoted as having better metabolic safety and tolerability but its adoption in dermatology remains limited due to lack of strong comparative evidence in skin diseases. Existing comparative studies mainly focus on specialties such as nephrology and rheumatology and do not provide dermatology specific evidence. This gap makes it important to evaluate the comparative clinical performance and safety of Prednisolone and Deflazacort in dermatology. This study is therefore justified to support safe and effective corticosteroid selection minimize side effects and improve treatment outcomes in steroid responsive dermatoses.

Objectives Primary objective To compare the clinical efficacy of Prednisolone and Deflazacort in steroid responsive dermatoses Secondary objective To compare the frequency and severity of adverse effects associated with Prednisolone and Deflazacort therapy

Methods and Methodology Study design Prospective comparative open label parallel group study conducted in the Dermatology Outpatient Department of a tertiary care teaching hospital Study setting Tertiary care teaching hospital located in Chengalpattu district Study population Patients attending the dermatology outpatient department during the study period

Sample size Based on earlier published studies the minimum required sample size is calculated as forty six participants with twenty three participants in each treatment group

Study period The duration of the study is eighteen months

Study tool A pretested validated structured questionnaire will be used to collect the following information Sociodemographic profile Clinical profile Treatment details

Ethical clearance Ethical approval will be obtained from the Institutional Human Ethics Committee of Chettinad Hospital and Research Institute before starting the study. Written informed consent will be obtained from all participants. Data confidentiality and participant anonymity will be maintained throughout the study.

Inclusion criteria Adults aged between eighteen and sixty five years Clinically diagnosed with steroid responsive dermatoses including atopic dermatitis allergic contact dermatitis irritant contact dermatitis lichen planus discoid lupus erythematosus urticaria with angioedema disseminated eczema and immunobullous disorders Requiring systemic corticosteroid therapy based on the decision of the treating dermatologist Willing and able to provide written informed consent Willing to comply with the study protocol and follow up visits

Exclusion criteria Known hypersensitivity or contraindication to Prednisolone or Deflazacort Presence of uncontrolled diabetes hypertension peptic ulcer disease or active infections including tuberculosis Current use of immunosuppressive medicines other than corticosteroids Pregnant or lactating women History of psychiatric illness or substance abuse affecting compliance Use of systemic corticosteroids within the last four weeks Known renal or hepatic dysfunction based on recent laboratory reports

Data collection Data collection will begin after ethical clearance and informed written consent. Data will be collected through interview using a pretested semi structured questionnaire.

Statistical analysis Data will be entered in Microsoft Excel and analyzed with statistical software. Quantitative variables will be expressed in descriptive statistics. Statistical significance will be determined using chi square test and probability value less than zero point zero five will be considered significant.

Sampling procedure and follow up schedule Eligible participants will be enrolled consecutively after informed consent until the required sample size is reached. Participants will be randomized in a one to one ratio into two groups Group A Prednisolone and Group B Deflazacort using a computer generated block randomization method. The study will be open label. Participants will be assessed at baseline and at regular intervals until the end of the study period. Follow up visits will be scheduled at day seven day fourteen day twenty eight week six and week eight. Outcome parameters such as lesion score symptom improvement treatment tolerability adverse effects and Dermatology Life Quality Index score will be recorded at each follow up. Unscheduled visits will be allowed for disease flares relapses or significant adverse effects. All adverse events will be documented and managed appropriately.

Study outcomes The study will determine the difference in clinical efficacy of Prednisolone and Deflazacort in steroid responsive dermatoses The study will compare the safety and frequency of adverse effects in both treatment groups The study will evaluate patient satisfaction and treatment adherence

Questionnaire

Section A Demographic and clinical information Age in years Gender male female or other Occupation Residence rural or urban Educational status illiterate primary school secondary school higher secondary graduate and above

Section B Baseline questions Alcohol consumption never occasionally or daily Tobacco use never smoker chewer or both Height in centimeters Weight in kilograms Body mass index History of comorbidities including hypertension diabetes asthma tuberculosis or others

Section C Clinical assessment Provisional dermatological diagnosis Duration of illness before treatment Presenting symptoms such as itching redness pain blistering scaling ulceration discoloration and others Baseline severity as assessed by physician mild moderate or severe Number of relapses in the past six months History of similar illness in family yes or no Previous systemic steroid use yes or no Current medications

Section D Treatment details Drug received Prednisolone or Deflazacort Initial dose Planned duration of treatment Tapering advised yes or no Concurrent medications Previous treatment received for skin disorder including none topical treatment only systemic corticosteroids or traditional alternative therapies Previous adverse reaction to steroids yes or no specify if yes Symptom improvement based on itching redness and lesions no improvement mild improvement moderate improvement marked improvement or complete clearance Number of days to first noticeable clinical improvement Overall disease control compared to baseline poor fair good or excellent

Section E Side effects during treatment Presence of the following during or after starting treatment Weight gain Facial puffiness or swelling Increased appetite Sleep disturbance Mood changes such as low mood anger or anxiety Acne or pimples Stomach pain or acidity Easy bruising or thin skin Muscle weakness especially arms or legs Frequent infections or general unwell feeling Stretch marks Any other side effects

Section F Dermatology Life Quality Index Evaluation of effect of skin disease on daily activities relationships personal confidence work studies social activities leisure activities sexual life and difficulties caused by treatment over the previous week. Total score will be computed out of thirty.