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Development of topical treatment with rapamycin for skin lesions of tuberous sclerosis complex

Development of topical treatment with rapamycin for skin lesions of tuberous sclerosis complex - Development of topical treatment with rapamycin for skin lesions of tuberous sclerosis complex

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002844
Enrollment
21
Registered
2009-12-03
Start date
2009-09-01
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

Interventions

Application of 0.2% Rapamycin ointment (ointment base is 0.03% tacrolimus ointment) on skin lesion of one side of the face twice a day for 12 weeks. Application of ointment base (control) on similar

Sponsors

Department of Dermatology Graduate School of Medicine, Osaka University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with a diagnosis of tuberous sclerosis complex made based on the clinical diagnostic criteria in guideline of Japanese Dermatological Association. 2) Patients who want to receive treatment for skin lesions of tuberous sclerosis complex. 3) Patients who cannot receive other effective treatment. 4) Patients who would not want to receive surgical treatment because of social circumstances or cosmetic reasons.

Exclusion criteria

Exclusion criteria: 1) Patients with severe mental retardation who cannot carry out this treatment plan. 2) Patients with a past history of hypersensitivity to macrolide antibiotics. 3) Patients who were judged unsuitable for this study by the investigator.

Design outcomes

Primary

MeasureTime frame
change in color and size of the skin lesions after 12 weeks topical treatment

Secondary

MeasureTime frame
change in shape appearance of contact dermatitis rapamycin levels in whole blood

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