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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs051200079
Enrollment
30
Registered
2020-11-04
Start date
2021-04-09
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

vitiligo vitiligo

Interventions

randomized controlled trial

Sponsors

Tsuruta Daisuke
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Contacts

Public ContactDaisuke Tsuruta

Osaka Metropolitan University Hosptial

dtsuruta@med.osaka-cu.ac.jp+81-6-6645-2121

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026