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investigator initiated study of Rhododenol-induced Leukoderma

investigator initiated study of Rhododenol-induced Leukoderma - Rhodo10

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000023244
Enrollment
10
Registered
2016-08-05
Start date
2016-08-05
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 once a day before bed time. The dose increase would be considered to twice a day (morning after cleansing and before bed time) after three months app

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)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 informed 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 who show allagic reaction against Bimatoprost. 5)Those women who are pregnant or possibly pregnant or during lactation or those who cannot agree with contraception during the study. 6)Those otherwise principal physician considered unsuitable to include in this study.

Design outcomes

Primary

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

Secondary

MeasureTime frame
1.The difference of six months from baseline as for, 1)Physician's evaluations on target region 2)Colorimeter values 3)Leukoderma sizes 2.Comparison between treated area and control area.

Countries

Japan

Contacts

Public ContactShinichi Watanabe

Teikyo University School of Medicine Department of Dermatology

watanabe@med.teikyo-u.ac.jp03-3964-1211(32609)

Outcome results

None listed

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