A Phase III study of Isotretinoin

JRCT ID: jRCT2031240401

Registered date:11/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Severe Recalcitrant Acne
• Date of first enrollment: 11/10/2024
• Target sample size: 70
• Study type: Interventional

Intervention(s)

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,

Outcome(s)

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

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: <= 49age old
• Gender: Both

Include criteria

(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

Exclude criteria

(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

Related Information

• Primary Sponsor: Toida Tsuneyuki