COMPARATIVE STUDY OF ORAL ISOTRETINOIN AS CONVENTIONAL, INTERMITTENT AND LOW DOSE REGIMEN IN MANAGEMENT OF ACNE VULGARIS.

Acne vulgaris is a persistent inflammatory skin disease that affects the hair follicles, caused by excess sebum production, inflammation, and microbial colonization. Clinically, pleomorphic lesions such as comedones, papules, pustules, nodules, and cysts are indicative of this condition. Typically, seborrheic regions such as the face, upper chest, and back of the trunk are impacted.AIM: To evaluate the clinical efficacy of conventional, intermittent, and low-dose Isotretinoin regimens in acne vulgaris using the Global Acne Grading System (GAGS).

 OBJECTIVES: • To compare the conventional, intermittent, and low-dose regimens of oral Isotretinoin in terms of efficacy, side effects, and compliance. • To evaluate the recurrence rates associated with Isotretinoin treatment regimens.

JUSTIFICATION FOR STUDY

Balancing Efficacy and Safety • Improving Patient Compliance: • Cost-Effectiveness: Lower-dose regimens can be more affordable • Reducing Relapse Rates: Continuous low-dose regimens have shown promise in maintaining long-term remission of acne with fewer relapses compared to intermittent dosing schedules. • Such research can lead to optimized acne management strategies that balance patient satisfaction and cost, ultimately improving outcomes for individuals affected by acne vulgaris.

 Methodology:

Source of data – Patients visiting the dermatology OP, CHRI

INCLUSION CRITERIA: • Patients with failure of first-line therapy.

• Moderate to severe acne frequently relapsing

• Moderate acne with imminent scarring

• Severe acne with nodules and cysts

• Inflammatory acne with scarring

• Patients who are married and not planning for pregnancy are advised to use contraceptives.

 EXCLUSION CRITERIA:

• Age less than 18 years

• Pregnancy, married females planning for pregnancy.

• Drug-induced acne.

• Abnormal liver functional tests, h/o Hyperlipidemia.

• Musculoskeletal deformity

 ·     Patients who fulfil the inclusion criteria will be allocated to the study.

·     • An informed consent letter will be obtained from the patient in their regional language after explaining the study in detail to them. Before starting Isotretinoin therapy, it is important to perform fasting lipid profile, Liver function tests, complete blood picture, blood glucose, and creatinine phosphokinase, Renal function test and ESR. Additionally, screening for cutaneous and ocular changes is necessary. Monitoring of lipid profile, Liver function tests, and kidney function tests should be done every 2 weeks for the first month and then once in a month.

• The patients will be divided into three groups for comparison of the efficacy of Isotretinoin.

72 patients will be randomized by random number generator app into 3 different groups of 24 each.

• Group C: Conventional dose of Isotretinoin will be administered as a dose of 0.5 mg/kg/day

• Group I: Intermittent dose of Isotretinoin will be administered as 0.5 mg/kg/day on alternate days.

• Group L: A Low dose of Isotretinoin will be administered as 0.2 mg/kg/day.

• All the groups will be given topical Clindamycin as a standard of care treatment.

• Withdrawal criteria from trial – • Patients who will not respond to a low dose of isotretinoin for 1 month will be shifted to the intermittent and Conventional group.

• A patient who will accidentally get pregnant needs to be immediately withdrawn from the trial.

. • Ultimately, it will be determined which group of patients will recover from lesions faster.

Study procedure:

The acne severity is evaluated with the Global Acne Grading System.

• This grading system quantifies lesions such as comedones, papules, pustules, and nodules, on various anatomical regions like the forehead, right cheek, left cheek, nose, chin, chest, and back. Each kind of lesion is assigned a grade based on its severity. • Additionally, each zone is assigned a factor ranging from 1 to 3, depending on its location.

• Location Factor Forehead 2 Right cheek 2 Left cheek 2 Nose 1 Chin 1 Chest and upper back 3 The score is derived by adding up the local scores across all zones.

• Global Acne Grading System score is the sum of local scores, and acne severity was graded as :- 1-18-Mild 19-30- Moderate 31-38- Severe >39-VerySevere

Expected duration of the subject participation:  2 months

Benefits of the Study (for participants and others):

1.   Effective Treatment**:** Access to isotretinoin, a proven medicine for moderate to severe acne.

2.   Lower Side Effects: Low-dose or intermittent treatment may work well with fewer problems like dryness.

3.   Regular Check-ups**:** Participants will be closely monitored, so any side effects can be managed early.

Possible Risks:

• Most common: dry lips (in about 90% of users).
• Other common: sun sensitivity, dry mouth, dry skin.
• Blood changes: raised triglycerides or ESR.

Confidentiality:

• Personal details will be kept private.
• Names will not appear in publications.

Treatment for Complications**:**

• No major risks expected.
• If any problem occurs, free treatment will be given at the hospital.

Voluntary Participation:

Requirement of blood samples: Yes, blood samples are required for blood investigations. Costs and source of investigations and drugs: He/She will not be charged for consultation. All the investigations will be done free of the cost.