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Showing 1–24 of 28 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Topical Sirolimus Clear all
Completed Phase 1 Interventional

Tuberous Sclerosis Complex: Facial Angiofibroma Skin Cream

NCT01853423
View directory record Official record
Conditions
Facial Angiofibroma
Interventions
Rapamune
Drug
Lead sponsor
Le Bonheur Children's Hospital
Other
Eligibility
3 Years to 45 Years
Enrollment
11 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2016
U.S. locations
1
States / cities
Memphis, Tennessee
Source: ClinicalTrials.gov public record
Updated Aug 18, 2016 · Synced Sep 12, 2026, 11:06 AM EDT
Active, not recruiting Phase 2 Interventional

A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 (Sirolimus) Topical Gel 3.9% in the Treatment of Cutaneous Venous Malformations

NCT06653842
View directory record Official record
Conditions
Cutaneous Venous Malformations
Interventions
QTORIN 3.9% rapamycin anhydrous gel
Drug
Lead sponsor
Palvella Therapeutics, Inc.
Industry
Eligibility
6 Years and older
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
10
States / cities
Irvine, California • Palo Alto, California • Aurora, Colorado + 7 more
Source: ClinicalTrials.gov public record
Updated Mar 26, 2026 · Synced Sep 12, 2026, 11:06 AM EDT
Completed Early Phase 1 Interventional Accepts healthy volunteers Results available

Topical-RAPA Use in Inflammation Reversal and Re-setting the Epigenetic Clock

NCT04608448
View directory record Official record
Conditions
Aging, Epigenetics, Inflammatory Mediators
Interventions
Rapamycin Topical Ointment, Placebo
Drug · Other
Lead sponsor
The University of Texas Health Science Center at San Antonio
Other
Eligibility
65 Years to 95 Years
Enrollment
22 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021 – 2022
U.S. locations
1
States / cities
San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Jul 18, 2023 · Synced Sep 12, 2026, 11:06 AM EDT
Completed Phase 1 Interventional

Re-administration of Intramuscular AAV9 in Patients With Late-Onset Pompe Disease

NCT02240407
View directory record Official record
Conditions
Pompe Disease
Interventions
Recombinant Adeno-Associated Virus Acid Alpha-Glucosidase, Rapamycin, saline, Rituxan, Diphenhydramine, Acetaminophen, Lidocaine, LMX 4 Topical Cream
Genetic · Drug · Other
Lead sponsor
University of Florida
Other
Eligibility
18 Years to 50 Years
Enrollment
2 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2021
U.S. locations
1
States / cities
Gainesville, Florida
Source: ClinicalTrials.gov public record
Updated Apr 4, 2022 · Synced Sep 12, 2026, 11:06 AM EDT
Completed Phase 2 Interventional

CODY: A Study Evaluating The Safety And Efficacy Of QTORIN 3.9% Sirolimus Topical Gel For The Prevention Of Basal Cell Carcinomas (BCCs) In Patients With Gorlin Syndrome

NCT04893486
View directory record Official record
Conditions
BCCs in Gorlin Syndrome Patients
Interventions
PTX-022, Vehicle comparator
Drug
Lead sponsor
Palvella Therapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
73 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2023
U.S. locations
14
States / cities
Scottsdale, Arizona • Hot Springs, Arkansas • Palo Alto, California + 11 more
Source: ClinicalTrials.gov public record
Updated Aug 28, 2024 · Synced Sep 12, 2026, 11:06 AM EDT
Completed Phase 2 Interventional

Evaluating the Safety and Efficacy of Topical Sirolimus 0.2% to Treat Acanthosis Nigricans

NCT06940895
View directory record Official record
Conditions
Acanthosis Nigricans
Interventions
Sirolimus 0.2%
Drug
Lead sponsor
Narrows Institute for Biomedical Research
Other
Eligibility
18 Years and older
Enrollment
5 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025
U.S. locations
1
States / cities
Brooklyn, New York
Source: ClinicalTrials.gov public record
Updated Nov 27, 2025 · Synced Sep 12, 2026, 11:06 AM EDT
Active, not recruiting Phase 3 Interventional

SELVA: A Phase 3 Study Evaluating QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations

NCT06239480
View directory record Official record
Conditions
Microcystic Lymphatic Malformation
Interventions
QTORIN 3.9% Rapamycin Anhydrous Gel
Drug
Lead sponsor
Palvella Therapeutics, Inc.
Industry
Eligibility
3 Years and older
Enrollment
51 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
15
States / cities
Irvine, California • Palo Alto, California • Atlanta, Georgia + 12 more
Source: ClinicalTrials.gov public record
Updated Mar 26, 2026 · Synced Sep 12, 2026, 11:06 AM EDT
Terminated Phase 2 Interventional Results available

An Open Label Phase II Trial of Topical Sirolimus for the Treatment of Refractory Oral Chronic Graft-versus-Host-Disease

NCT02123966
View directory record Official record
Conditions
Chronic Graft-versus-Host-Disease, Oral Mucosal Disease Due to Graft-versus-host Disease
Interventions
Sirolimus
Drug
Lead sponsor
Dana-Farber Cancer Institute
Other
Eligibility
4 Years and older
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2016
U.S. locations
2
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Jul 23, 2018 · Synced Sep 12, 2026, 11:06 AM EDT
Terminated Phase 2 Interventional Results available

Topical Sirolimus Ointment for Cutaneous Angiofibromas in Subjects With Tuberous Sclerosis Complex

NCT03363763
View directory record Official record
Conditions
Angiofibroma of Face, Tuberous Sclerosis
Interventions
Sirolimus 0.2%, Sirolimus 0.4%, Placebo ointment
Drug
Lead sponsor
Aucta Pharmaceuticals, Inc
Industry
Eligibility
2 Years to 21 Years
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2023
U.S. locations
7
States / cities
Phoenix, Arizona • Los Angeles, California • Aurora, Colorado + 4 more
Source: ClinicalTrials.gov public record
Updated Nov 30, 2025 · Synced Sep 12, 2026, 11:06 AM EDT
Not yet recruiting Phase 1 Interventional

Topical TOR-582 Treatment of Epistaxis in HHT

NCT07667413
View directory record Official record
Conditions
Hereditary Hemorrhagic Telangiectasia (HHT), Epistaxis
Interventions
Topical sirolimus ointment
Drug
Lead sponsor
Columbia University
Other
Eligibility
18 Years and older
Enrollment
27 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2027
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Aug 20, 2026 · Synced Sep 12, 2026, 11:06 AM EDT
Not yet recruiting Early Phase 1 Interventional

A Pilot Study to Examine the Efficacy and Tolerability of Sirolimus on Epidermal Nevi Lesions in Patients 6 Years Old and Above.

NCT07813533
View directory record Official record
Conditions
Epidermal Nevi
Interventions
sirolimus topical gel 0.2%
Drug
Lead sponsor
Northwestern University
Other
Eligibility
6 Years and older
Enrollment
14 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Sep 9, 2026 · Synced Sep 12, 2026, 11:06 AM EDT
Active, not recruiting Phase 2 Interventional

Daily Topical Rapamycin for Vitiligo

NCT05342519
View directory record Official record
Conditions
Vitiligo
Interventions
Rapamycin, Placebo
Drug
Lead sponsor
Medical University of South Carolina
Other
Eligibility
13 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2027
U.S. locations
1
States / cities
Charleston, South Carolina
Source: ClinicalTrials.gov public record
Updated Mar 4, 2026 · Synced Sep 12, 2026, 11:06 AM EDT
Completed Phase 2Phase 3 Interventional Results available

Dose-Ranging Efficacy and Safety Study of Topical Rapamycin Cream for Facial Angiofibroma Associated With Tuberous Sclerosis Complex

NCT03826628
View directory record Official record
Conditions
Facial Angiofibroma, Tuberous Sclerosis
Interventions
rapamycin, placebo
Drug
Lead sponsor
Dermatology Specialties Limited Partnership
Industry
Eligibility
6 Years to 65 Years
Enrollment
107 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
6
States / cities
Phoenix, Arizona • La Jolla, California • St. Petersburg, Florida + 3 more
Source: ClinicalTrials.gov public record
Updated Sep 7, 2023 · Synced Sep 12, 2026, 11:06 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Phase 1 Study of the Effects of Combining Topical FDA-approved Drugs on Age-related Pathways on the Skin of Healthy Volunteers

NCT03072485
View directory record Official record
Conditions
Aging
Interventions
Sirolimus, Metformin, Diclofenac
Drug
Lead sponsor
Anne Chang
Other
Eligibility
55 Years and older · Female only
Enrollment
10 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2017 – 2019
U.S. locations
1
States / cities
Redwood City, California
Source: ClinicalTrials.gov public record
Updated Mar 31, 2019 · Synced Sep 12, 2026, 11:06 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

NPC-12G Gel 0.2% Sirolimus PK Bridging Study

NCT03972462
View directory record Official record
Conditions
Bioavailability Study
Interventions
NPC-12G Gel 0.2%, Rapamune® 2 mg tablet
Drug
Lead sponsor
Nobelpharma
Industry
Eligibility
18 Years to 65 Years
Enrollment
12 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2019
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Mar 5, 2020 · Synced Sep 12, 2026, 11:06 AM EDT
Completed Phase 1Phase 2 Interventional Accepts healthy volunteers

Novel Compositions for Treating or Preventing Dermal Disorders

NCT03103893
View directory record Official record
Conditions
Dermal Atrophy
Interventions
Rapamycin
Drug
Lead sponsor
Drexel University
Other
Eligibility
40 Years to 100 Years
Enrollment
36 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2017
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Sep 21, 2021 · Synced Sep 12, 2026, 11:06 AM EDT
Completed Phase 2 Interventional Results available

Using Topical Sirolimus 2% for Patients With Epidermolysis Bullous Simplex (EBS) Study

NCT02960997
View directory record Official record
Conditions
Epidermolysis Bullosa Simplex, Epidermolysis Bullosa Simplex Kobner, Weber-Cockayne Syndrome
Interventions
Sirolimus, 2%, Vehicle
Drug
Lead sponsor
Stanford University
Other
Eligibility
4 Years and older
Enrollment
8 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2021
U.S. locations
1
States / cities
Palo Alto, California
Source: ClinicalTrials.gov public record
Updated Mar 8, 2022 · Synced Sep 12, 2026, 11:06 AM EDT
Active, not recruiting Phase 3 Interventional Accepts healthy volunteers

Combination Gerotherapeutic Interventions for Healthspan Improvement

NCT07475546
View directory record Official record
Conditions
Healthspan Improvement, Aging, Longevity
Interventions
Rapamycin, Naltrexone, Metformin, NAD+, GSH, Infinite Supplement, Placebo/control, B12, Intervention: Guided Meditation Program, Control: Podcast Listening Activity, Control: Standard Exercise Regimen, Intervention: Structured Exercise Program
Drug · Dietary Supplement · Behavioral
Lead sponsor
AgelessRx
Industry
Eligibility
60 Years to 80 Years
Enrollment
30 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2025 – 2026
U.S. locations
1
States / cities
Ann Arbor, Michigan
Source: ClinicalTrials.gov public record
Updated Mar 15, 2026 · Synced Sep 12, 2026, 11:06 AM EDT
Completed Early Phase 1 Interventional Accepts healthy volunteers Results available

RAPA-Keloid Study of Keloid Regression

NCT04049552
View directory record Official record
Conditions
Keloid
Interventions
Rapamycin 8% Ointment, Placebo
Drug
Lead sponsor
The University of Texas Health Science Center at San Antonio
Other
Eligibility
18 Years to 75 Years
Enrollment
4 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2021
U.S. locations
1
States / cities
San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Sep 28, 2021 · Synced Sep 12, 2026, 11:06 AM EDT
Withdrawn Phase 2 Interventional

Therapeutic Efficacy of Topical Sirolimus in Early Stage Cutaneous T-cell Lymphoma (CTCL)

NCT01843998
View directory record Official record
Conditions
Cutaneous T-cell Lymphoma (CTCL)
Interventions
Sirolimus 0.1% Ointment
Drug
Lead sponsor
Stefan Schieke MD
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
1
States / cities
Milwaukee, Wisconsin
Source: ClinicalTrials.gov public record
Updated Jun 3, 2015 · Synced Sep 12, 2026, 11:06 AM EDT
Completed Phase 2 Interventional Results available

Study Evaluating the Safety and Efficacy of PTX-022 (QTORIN Sirolimus) in the Treatment of Microcystic Lymphatic Malformations

NCT05050149
View directory record Official record
Conditions
Microcystic Lymphatic Malformation
Interventions
PTX-022
Drug
Lead sponsor
Palvella Therapeutics, Inc.
Industry
Eligibility
6 Years and older
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022
U.S. locations
7
States / cities
Little Rock, Arkansas • Palo Alto, California • Fridley, Minnesota + 4 more
Source: ClinicalTrials.gov public record
Updated Jan 16, 2025 · Synced Sep 12, 2026, 11:06 AM EDT
Completed Phase 1 Interventional Results available

Topical Sirolimus for the Treatment of Pachyonychia Congenita (PC)

NCT02152007
View directory record Official record
Conditions
Pachyonychia Congenita
Interventions
1% sirolimus cream (TD201 1%)
Drug
Lead sponsor
TransDerm, Inc.
Industry
Eligibility
16 Years and older
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
1
States / cities
Stanford, California
Source: ClinicalTrials.gov public record
Updated Oct 6, 2016 · Synced Sep 12, 2026, 11:06 AM EDT
Recruiting Phase 2 Interventional

A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 (Sirolimus) Topical Gel 3.9% in the Treatment of Angiokeratomas (LOTU)

NCT07552077
View directory record Official record
Conditions
Angiokeratomas
Interventions
PTX-022
Drug
Lead sponsor
Palvella Therapeutics, Inc.
Industry
Eligibility
6 Years and older
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2027
U.S. locations
4
States / cities
Sherman Oaks, California • Dawsonville, Georgia • Las Vegas, Nevada + 1 more
Source: ClinicalTrials.gov public record
Updated Apr 26, 2026 · Synced Sep 12, 2026, 11:06 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Topical Rapamycin Therapy to Alleviate Cutaneous Manifestations of Tuberous Sclerosis Complex (TSC) and Neurofibromatosis I (NF1)

NCT01031901
View directory record Official record
Conditions
Tuberous Sclerosis, Neurofibromatoses, Angiofibroma, Neurofibroma
Interventions
Skincerity, Skincerity plus sirolimus/rapamycin, Skinercity plus sirolimus/rapamycin
Drug
Lead sponsor
The University of Texas Health Science Center, Houston
Other
Eligibility
13 Years and older
Enrollment
52 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2009 – 2011
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Feb 26, 2012 · Synced Sep 12, 2026, 11:06 AM EDT