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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000002844
Date of registration:	03/12/2009
Prospective Registration:	No
Primary sponsor:	Department of Dermatology Graduate School of Medicine, Osaka University
Public title:	Development of topical treatment with rapamycin for skin lesions of tuberous sclerosis complex
Scientific title:	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
Date of first enrolment:	2009/09/01
Target sample size:	21
Recruitment status:	Complete: follow-up complete
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003457
Study type:	Interventional
Study design:	Parallel Non-randomized
Phase:	Phase II,III

Countries of recruitment
Japan

Contacts

Name:	Mari Wataya-Kaneda
Address:	2-2, Yamadaoka, Suita, Osaka 565-0871, JAPAN Japan
Telephone:	06-6879-3031
Email:	mkaneda@derma.med.osaka-u.ac.jp
Affiliation:	Graduate School of Medicine, Osaka University Department of Dermatology

Name:	Mari Wataya-Kaneda
Address:	2-2, Yamadaoka, Suita, Osaka 565-0871, JAPAN Japan
Telephone:	06-6879-3031
Email:	mkaneda@derma.med.osaka-u.ac.jp
Affiliation:	Graduate School of Medicine, Osaka University Department of Dermatology

Key inclusion & exclusion criteria

Inclusion 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.

Age minimum: Not applicable
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

tuberous sclerosis complex

Intervention(s)

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 skin lesion of the other side of the face twice a day for 12 weeks.
Application of 0.2% Rapamycin ointment (ointment base is white petrolatum) on skin lesion of one side of the face twice a day for 12 weeks. Application of ointment base (control) on similar skin lesion of the other side of the face twice a day for 12 weeks.
Application of 0.2% Rapamycin gel (base is carboxyvinyl polymer) on skin lesion of one side of the face twice a day for 12 weeks. Application of gel base (control) on similar skin lesion of the other side of the face twice a day for 12 weeks.

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

Source(s) of Monetary Support

Ministry of Health, Labour and Welfare

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date:
Contact:

Results

Results available:
Date Posted:
Date Completed:	29/07/2013
URL:

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