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investigator initiated study of long-term treatment of Rhododenol-induced Leukoderma with Bimaprost

investigator initiated study of long-term treatment of Rhododenol-induced Leukoderma with Bimaprost - investigator initiated study of long-term treatment of Rhododenol-induced Leukoderma with Bimaprost

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000030316
Enrollment
10
Registered
2017-12-12
Start date
2017-12-15
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

Rhododenol-induced Leukoderma

Interventions

Bimatoprost would be applied on the target region. The number of times to apply on the skin would follow the same number of times at the end of previous study &quot
investigator initiated study of Rhododenol-induced Leukoderma&quot

Sponsors

Teikyo University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients diagnosed as Rhododenol-induced Leukoderma according to diagnostic criteria of Japanese Dermatology Association (meeting all contents of essential diagnostic criteria and meeting at least one content of minor diagnostic criteria) a) essential diagnostic criteria i) Used Rhododenol containing cosmetics ii) Not having Leukoderma before using Rhododenol containing cosmetics. Complete or incomplete depigmented area emerged after use of Rhododenol containing cosmetics on mostly Rhododenol applied area. b) Minor diagnostic criteria i) The enlargement of Leukoderma stopped within a month after withdrawal of Rhododenol containing cosmetics. ii) After withdrawal of Rhododenol containing cosmetics, at least part of Leukoderma became re-pigmented. 2) The participant of the previous study and who also completed the observation period. 3) From the point of view of the efficacy and safety, those who were considered resonable by pricipal investigator or sub-investigator to be included in the subsequent study. 4) Those subjects who want to participate in the subsequent study after completing the previous study. 5) All participants are fully explained about the aim, content and expected side effects of the study. After confirming the participants' understanding, written informed consent is taken under their free will.

Exclusion criteria

Exclusion criteria: 1) Age under twenty years old at the time of inforomed consent. 2) Those who were suspected of concomitant vitiligo vulgaris. 3) Those who show skin problems such as erythema at the site of target region. 4) Those subjects who were considered by the principal investigator or sub-investigator to be showing skin problem which might be related to previous study. 5) Those subjects who were considered by the principal investigator or sub-investigator to be difficult to comply with compliance. 6) Those who show allagic reaction against Bimatoprost. 7) Those women who are pregnant or possibly pregnant or during lactation or those who cannot agree with contraception during the study. 8) Those otherwise principal physician considered unsuitable to include in this study.

Design outcomes

Primary

MeasureTime frame
Degree of pigmentation after twelve months application of Bimatoprost on target region.

Countries

Japan

Contacts

Public ContactYayoi tada

Teikyo University School of Medicine Department of Dermatology

tada@df6.so-net.ne.jp03-3964-1211

Outcome results

None listed

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