Clinical trial for development of topical rapamycin treatment for white macules due to tuberous sclerosis complex, vitiligo vulgaris, and other congenital diseases

Clinical trial for development of topical rapamycin treatment for white macules due to tuberous sclerosis complex, vitiligo vulgaris, and other congenital diseases - Clinical trial for development of topical rapamycin treatment for white macules due to tuberous sclerosis complex, vitiligo vulgaris, and other congenital diseases

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006108

Enrollment

Registered

2011-08-03

Start date

2011-08-01

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

tuberous sclerosis complex, vitiligo vulgaris, white macules due to congenital diseases

Interventions

Application of 0.2% rapamycin gel (base is carboxyvinyl polymer) on white macules of the face twice a day for 12 weeks. When it is possible, application of 0.2% rapamycin gel twice a day for 12 week

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients diagnosed as tuberous sclerosis complex based on the clinical diagnostic criteria in guideline of Japanese Dermatological Association, or patients diagnosed clinically as vitiligo vulgaris, piebaldism, hypomelanosis of Ito, or nevus depigmentosus. 2) Patients who want treatment for white macules. 3) Patients who cannot receive other effective treatments. 4) Patients who would not want to receive other treatments because of social or cosmetic reasons.

Exclusion criteria

Exclusion criteria: 1) Patients with severe mental retardation who cannot carry out this treatment plan. 2) Patients who have allergy to macrolide antibiotics. 3) Patients who received oral administration of rapamycin or RAD001 within six months prior to the study entry. 4) Patients who received topical treatment of tacrolimus, vitamin D, or steroid within three months prior to the study entry. 5) Patients who received phototherapy or surgical therapy within six months prior to the study entry. 6) Patients during pregnancy or lactation 7) Patients who were judged unsuitable for this study by the investigator.

Design outcomes

Primary

Measure	Time frame
Changes in color and size of white macules at 4, 8, and 12 weeks	—

Secondary

Measure	Time frame
Appearance of contact dermatitis Rapamycin levels in whole blood Numbers and shapes of melanocyte in specimens of skin tissue in the cases who agree with skin biopsy	—

Countries

Japan

Contacts

Public ContactMari Wataya-Kaneda

Graduate School of Medicine, Osaka University Department of Dermatology

mkaneda@derma.med.osaka-u.ac.jp06-6879-3031

Outcome results

None listed

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