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A study to understand the effect of anti-acne medication and overall improvement in patients with severe acne.

Effectiveness and Tolerability of Low-Dose Micronized-Isotretinoin in Patients with Severe Recalcitrant Nodular Facial Acne: A Real-World Retrospective Study from Electronic Medical Records - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/07/070813
Enrollment
300
Registered
2024-07-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L700- Acne vulgaris

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Sun Pharmaceutical Industries Ltd. (SPIL)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female greater than equal to 12 years of age 2. Patients diagnosed with severe recalcitrant nodular facial acne by treating dermatologist 3. Patient who completed at least 8 weeks of therapy with low dose micronized-isotretinoin (Sotret® NF)

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating females 2. Patient who had already taken conventional or micronized isotretinoin in the past 3. Known hypersensitivity to isotretinoin

Design outcomes

Primary

MeasureTime frame
Improvement in severity of acne based on Investigator’s Global Assessment (IGA) scale (score 0-4) from baseline to 8 + or - 2 weeks of treatmentTimepoint: Baseline to 8 + or - 2 weeks—

Secondary

MeasureTime frame
1. Improvement in severity of acne based on Investigator’s Global Assessment (IGA) scale (score 0-4) from baseline to end of treatment, upon stratification of patients based on duration of treatmentTimepoint: Baseline to End of treatment;2. Response to treatment as assessed and graded by investigator from baseline to end of treatment, upon stratification of patients based on duration of treatment as follows- a. more than 75 percentage clearing is equal to excellent, b. 50-75 percentage clearing is equal to good, c. 25-50 percentage clearing is equal to fair, and d. less than 25 percentage clearing is equal to poorTimepoint: Baseline to End of treatment;Change in total number of lesions from baseline to end of treatmentTimepoint: Baseline to End of treatment;Change in total number of nodular lesions from baseline to end of treatmentTimepoint: Baseline to End of treatment;Proportion of patients with adverse events (AEs) and serious AEs (SAEs)Timepoint: Baseline to End of treatment;Response to treatment graded by patient from baseline to end of treatment as follows: (1 is equal to very good, 2 is equal to good, 3 is equal to average, 4 is equal to poor)Timepoint: Baseline to End of treatment—

Countries

India

Contacts

Public ContactMs Colette Pinto

Sun Pharmaceutical Industries Ltd.

Mukesh.Gabhane@sunpharma.com02243244324

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 8, 2026