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A Double-Blind, Randomized, Phase 3, Parallel group, Multi-center study, Evaluating the Efficacy and Safety of Isotretinoin in Patients with Severe Recalcitrant Acne

A Phase III study of Isotretinoin

Toida Tsuneyuki

Sun Pharma Japan Limited

KDX Hamamatsucho Place 1-7-6 Shibakoen, Minato-ku, Tokyo

JPS.clinicaltrial@sunpharma.com

Contact for Clinical Trial Information

Sun Pharma Japan Limited

KDX Hamamatsucho Place 1-7-6 Shibakoen, Minato-ku, Tokyo

+81-3-6432-0201

JPS.clinicaltrial@sunpharma.com

Pending

Oct. 11, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

(1) Patients aged between 12 and 49 years with acne.
(2) Patients with at least 10 inflammatory nodules/cysts.
(3) Patients with IGA greater than or equal to 4 (Severe)
(4) Patients who have previously received the treatments for acne for a certain duration but are not responding

(1) Patients with serious cardiac, hepatic, renal, pulmonary, hematologic diseases, etc., history or complications considered inappropriate by the investigator to participate in the study.
(2) Patients who have not passed 120 days on the first day of treatment, after participation (the last dose of the study drugs or test drugs) in other clinical studies, post-marketing clinical studies, or clinical research, or who are currently participating in other clinical studies, post-marketing clinical studies or clinical research.
(3) Patients who are pregnant or lactating, patients who may be pregnant, or patients who are unwilling to use contraception in an appropriate manner as instructed by the investigator during the study period.
(4) Patients with a history or complications of mental disorders (depression, psychosis, suicidal ideation, etc.)
(5) Patients with a history or complications of severe ocular disorders (corneal opacity, decreased night vision, keratitis, etc.)
(6) Patients with severe musculoskeletal or connective tissue disorders (e.g., severe arthralgia, myalgia, low back pain, muscle cramps, rhabdomyolysis)
(7) Patients who are considered by the investigator to be ineligible for the study

Both

Severe Recalcitrant Acne

The study drug will be taken orally twice daily. The dosage will be determined based on the body weight on the day of randomization.
During the first 4 weeks approximately 0.4 mg/kg/day will be administered. The treatment dose will be increased to approximately 0.8 mg/kg/day for the rest 16 weeks,

The proportion of patients with at least a 90% reduction from Baseline to Week 20 in the total number of inflammatory nodular/cystic lesions

1. Percentage change and number of change in total number of inflammatory nodular/cystic lesions
2. Proportion of patients with a certain reduction in the total number of inflammatory nodular/cystic lesions
3. Proportion of patients with IGA success (IGA score 0 or 1)
4. Percentage change and number of change in the total number of inflammatory lesions
5. Percentage change of reduction in DLQI/CDLQI score

No

none