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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00928798
Other study ID # 09-2-058
Secondary ID
Status Completed
Phase Phase 3
First received June 25, 2009
Last updated March 7, 2012
Start date January 2010
Est. completion date August 2011

Study information

Verified date March 2012
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial Summary

The purpose of the study is to determine whether topical application of rapamycin can lead to reduction in size and/or number of fibrofolliculomas in BHD patients and may prevent the growth of new ones. Secondary we evaluate rapamycin safety, formula acceptance and patient satisfaction.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date August 2011
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Minimum age of 18 years.

- At least 10 facial fibrofolliculomas, histologically confirmed.

- Entered in a screening program and free of malignancy as determined during screening (already had a baseline MRI or CT-scan).

- Being able to understand instructions.

- Mutation status must be known.

- For females: not pregnant and willing to use both oral and barrier contraceptives during the treatment period.

Exclusion Criteria:

- Not capable of informed consent.

- Age under 18 years.

- Pregnancy or failure to comply with contraceptive measures.

- Proven or suspected malignancy of skin or other organs.

- No histological confirmation.

- Skin lesions other than fibrofolliculoma that might worsen under sirolimus such as active infections.

- Not able to comprehend instructions.

- No proven mutation.

- Less than 10 fibrofolliculomas.

- Planned facial surgery in the treatment period.

- Concomitant disease requiring systemic immunosuppressive treatment

- Concomitant disease requiring facial topical immunosuppressive treatment or facial topical drugs that interfere with rapamycin during trail period or in the 30 days before start trial.

- Tendency to form keloids or hypertrophic scars.

- Drug or alcohol abuse.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Rapamycin
Application of rapamycin 1 mg/ml oral solution to one predefined skin area on one facial half, twice daily 0,25 ml, during 6 months. The other facial half will be similarly treated with a placebo.
placebo
Application of placebo to one predefined skin area on one facial half, during 6 months. The other facial half will be similarly treated with rapamycin 1 mg/ml oral solution

Locations

Country Name City State
Netherlands VU Medical Centre Amsterdam Amsterdam
Netherlands Maastricht University Medical Centre Maastricht

Sponsors (2)

Lead Sponsor Collaborator
Maastricht University Medical Center Myrovlytis Trust

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Significant regression of lesions (reduction of fibrofolliculoma size and count) in the treated area. 3 and 6 months No
Secondary Side effects 3 and 6 months Yes