Not Yet RecruitingPhase 2Phase 3ACTRN12625000983404

Comparing the therapeutic efficacy of oral low dose versus pulsed dose oral isotretinoin in moderate acne vulgaris patients presenting in PNS Shifa Hospital, Karachi

Sponsor

PNS Shifa

Enrollment

90 participants

Start Date

Oct 1, 2025

Study Type

Interventional

Conditions

Acne vulgaris

Summary

A comparative study of low dose daily 20 mg isotretinoin oral capsule with weekly pulse dose of 1 mg/kg/day of isotretinoin oral capsule for 1 week of the month (4 weeks) in moderate acne, will be conducted at Dermatology out-patient department, PNS shifa hospital Karachi. After written consent,90 patients will be divided in Group A & B. Patients in both the groups will receive treatment for 6 months and data from the patient will be collected through a proforma on first visit and follow-ups.

Eligibility

Sex: Both males and femalesMin Age: 12 Yearss

Inclusion Criteria6

Non pregnant females , unmarried females , not planning conception for 2 years
Both female and male
Age above 12 years willing to undergo treatment and follow up
Patients without any known systemic illness
Patients not taking any other treatment for last 3 months
Patients with moderate acne only that is several to many papules / pustules with few to severe nodules

Exclusion Criteria7

Pregnant females, married females, desiring to get pregnant or using temporary methods of contraception
Patients having family or personal history of hyperlipidemia, diabetes, renal or hepatic disease
Patients having drug-induced acne
Patients known to be hypersensitive to isotretinoin or unwilling for investigations
Patients using other therapies for acne vulgaris
Patient age less than 12 years
Patients with mild or severe acne vulgaris

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Interventions

Patients will be divided into two groups. Group A will receive low dose isotretinoin 20 mg oral capsule daily and Group B will receive pulsed dose of 1 mg/kg/day oral capsule for 1 week in the whole month( 4 weeks). Patients assigned to either groups using the sequential method. Patients will receive treatment for 6 months. All the patients will be provided with the same brand of medicine to minimize brand bias. Primary endpoint will be photographic score at the end of 6 months from baseline. Standardized digital photographs of the acne affected area will be taken every month with the patient in a similar position to ensure consistency of photography. Treatment response will be evaluated on a standardized 4-point rating scale calculated at the end of 6 months following completion of treatment , as indicated with help of ( annexure C ) - Global Acne Grading System. 0 = completely cleared (100% improved from baseline Acne severity index), 1 = marked improvement ( > 75% improved from baseline Acne severity index), 2 = moderate improvement ( 50–75% improved from baseline Acne severity index), 3 = mild improvement ( 25-50% improved from baseline Acne severity index ), 4 = insignificant improvement ( <25% improved from baseline Acne severity index) .. Safety evaluations will be done on monthly visits by asking patients about any adverse effects related to medication. Baseline investigations using CBC, LFT, lipid profile and urine pregnancy test ( females of child bearing age ) will be done before starting treatment and follow up investigations at end of first, third and sixth month of treatment. Female participants will get treatment only after their next menstrual period to ensure that they are not pregnant at time of treatment initiation. The participants were also followed up for 8 months after completion of treatment to look for any relapse.