An open-label, intergroup study to evaluate the efficacy and safety of N-acetyl-cysteine in patients with vitiligo.
- Conditions
- vitiligo
- Registration Number
- JPRN-jRCTs051200079
- Lead Sponsor
- Tsuruta Daisuke
- Brief Summary
o statistically significant difference was noted between the both groups in changes in vitiligo image evaluation during the 3-month comparative period, which was the primary endpoint. No significant results were noted as well for other secondary efficacy endpoints. In safety, adverse events (AEs) were reported in 11 of 20 subjects (55.0%) and adverse drug reactions (ADRs) in 4 of 20 subjects (20.0%). No deaths or serious AEs were reported, and no clinically problematic AEs or ADRs were found.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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<br>2)Quantitative evaluation of vitiligo based on images of vitiligo sites to be evaluated in the comparison period and continuous observation<br>3)Changes in blood glutathione concentration during the comparison period and the continuous observation period<br>4)Changes in QOL scores during the comparison period and the continuous observation period