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. 2016 Jul 13;2016(7):CD011272. doi: 10.1002/14651858.CD011272.pub2

NCT01526356.

Methods Multicentre prospective, randomised, double‐blind, placebo‐controlled study.
Participants 177 participants diagnosed with TSC and visible facial angiofibromas.
Interventions Participants were randomised into either:
1. topical placebo cream;
OR
2. topical 0.1% rapamycin cream;
OR
3. topical 1% rapamycin cream.
Study cream is applied nightly to the affected areas on the face.
Outcomes Primary outcome: reduction in lesion size and appearance. Photographic, visual, and measurable reduction in the size and severity of the lesions.
Secondary outcomes: systemic uptake of topically applied rapamycin; dermatologic sensitivity at the site of application.
Notes Sponsored by The University of Texas Health Science Center, Houston.

IQ: intelligence quotient
 TSC: tuberous sclerosis complex