An open-label, intergroup study to evaluate the efficacy and safety of N-acetyl-cysteine in patients with vitiligo.

JRCT ID: jRCTs051200079

Registered date:04/11/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: vitiligo
• Date of first enrollment: 09/04/2021
• Target sample size: 30
• Study type: Interventional
• Intervention(s): randomized controlled trial

Outcome(s)

• Primary Outcome: 1) Comparison of NAC-administered group and non-NAC-administered group based on 3-grade evaluation of vitiligo image in comparison period (improvement: +1, unchanged: 0, worsening: -1)

Secondary Outcome

1) Changes in three-step evaluation of vitiligo images (improved: +1, unchanged: 0, worsened: -1) by continuous administration of NAC during the continuous observation period
2)Quantitative evaluation of vitiligo based on images of vitiligo sites to be evaluated in the comparison period and continuous observation
3)Changes in blood glutathione concentration during the comparison period and the continuous observation period
4)Changes in QOL scores during the comparison period and the continuous observation period

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Patients diagnosed with vitiligo
2)Written informed consent by his or her own will
3)20 years old over (Both of male and female)
4)Patients judged by physicians to be poorly effective with standard drugs and phototherapy

Exclude criteria

1)Patients treated for new vitiligo from consent to qualification
2)Patients with skin diseases other than vitiligo
3)Patients with food allergy, bronchial asthma, drug allergy
4)Using sumatriptan or mucofilin
5)Patients at risk for gastric bleeding
6)Patients with severe liver damage (fulminant hepatitis, cirrhosis, liver tumor, jaundice that spreads for more than 6 months)
7)Patients with severe renal impairment (nephrotic syndrome, acute renal failure, chronic renal failure, uremia, hydronephrosis)
8)Patients with infectious disease (HBV, HCV, HIV, HTLV-1)
9) Pregnant, possibly pregnant or breast feeding and hope to get pregnant during this study
10)The physicians consider that the patients are inappropriate for this study
11)The patient who smokes at the time of the agreement acquisition and cannot give up smoking during a study period

Related Information

• Primary Sponsor: Tsuruta Daisuke
• Source(s) of Monetary Support: Kao Corporation