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Clinical trial for development of topical rapamycin treatment for rosacea

Clinical trial for development of topical rapamycin treatment for rosacea - Clinical trial for development of topical rapamycin treatment for rosacea

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000008315
Enrollment
5
Registered
2012-07-02
Start date
2012-07-01
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

rosacea

Interventions

The similar eruptions of rosacea on both sides of the face are chosen as the treatment lesions. 0.2% rapamycin ointment is applied on the skin lesion on the right, and the ointment base or the ointm

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with rosacea who come to our outpatient department. 2) Patients who are resistant to previous treatment. 3) Patients who want to receive the treatment with the rapamycin ointment. 4) Patients who have not received topical steroid treatment for more than 2 months in the previous year.

Exclusion criteria

Exclusion criteria: 1) Patients who cannot comply with the treatment plan. 2) Patients who are allergic 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 oral administration of macrolide antibiotics for more than 7 days within three months prior to the study entry. 5) Patients who received topical steroid treatment within three months prior to the study entry. 6) Patients who received topical treatment of tacrolimus, nadifloxacin, clindamycin or adapalene within a month prior to the study entry. 7) Patients who have a large wound or scar on the face, which would interfere the treatment or the assessment. 8) Patients who are pregnant or lactating. 9) Patients under 18 years of age. 10) Patients who were judged unsuitable for this study by the investigator.

Design outcomes

Primary

MeasureTime frame
Changes in redness and size of eruptions after 4 and 8 weeks of treatment, and at 4 and 8 weeks after end of treatment

Secondary

MeasureTime frame
Appearance of contact dermatitis Rapamycin levels in whole blood histological findings 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