Trial · NCT03826628
Dose-Ranging Efficacy and Safety Study of Topical Rapamycin Cream for Facial Angiofibroma Associated With Tuberous Sclerosis Complex
NCT03826628, Phase 2, Phase 3, Completed, Dermatology Specialties Limited Partnership; results first posted 2023-08-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dose-Ranging Efficacy and Safety Study of Topical Rapamycin Cream for Facial Angiofibroma Associated With Tuberous Sclerosis Complex. Trials, record NCT03826628. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03826628
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose-Ranging Efficacy and Safety Study of Topical Rapamycin Cream for Facial Angiofibroma Associated With Tuberous Sclerosis Complex
- NCT number
- NCT03826628
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 107 participants, actual
- Lead sponsor
- Dermatology Specialties Limited Partnership
- Conditions
- Facial Angiofibroma, Tuberous Sclerosis
- Interventions
- rapamycin, placebo
- First posted
- 2019-02-01
- Last updated
- 2023-09-08
- Results first posted
- 2023-08-14
- Limitations and caveats
- Covid-19 pandemic halted recruitment, leading to a smaller number of patients recruited than intended (107/120).
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Obtaining Successful Treatment | After 26 weeks treatment | Success on the Investigator Global Assessment (IGA) scale is defined as clear or almost clear with an improvement of at least two grades from baseline. IGA scores range from 0-4: 0=Clear 1. Almost Clear 2. Mild 3. Moderate 4. Severe |
| Secondary | Time to Treatment Success | From first dose to 26 weeks (± 2 weeks) | The time elapsed from the first dose to the time of treatment success, according to the Investigator's Global Assessment (IGA) scale. The total time of treatment was 26 weeks, although Covid-19 visit delays led to an extension of up to 2 weeks (28 weeks total) for some patients. Success on the Investigator Global Assessment (IGA) scale is defined as clear or almost clear with an improvement of at least two grades from baseline. IGA scores range from 0-4: 0=Clear 1. Almost Clear 2. Mild 3. Moderate 4. Severe |
| Secondary | Change From Baseline in Investigator's Global Assessment | At baseline and after 26 weeks treatment | The change in grading on the Investigator's Global Assessment (IGA) scale from baseline. IGA scores range from 0-4: 0=Clear 1. Almost Clear 2. Mild 3. Moderate 4. Severe |
| Secondary | Change From Baseline in Facial Angiofibroma Severity Index (FASI) | At baseline and after 26 weeks treatment | The change in grading on the Facial Angiofibroma Severity Index (FASI) from baseline. FASI grades lesions according to their erythema, size and extent by summing the scores of each category. The final FASI scores range from (mild) 2-9 (severe). Erythema Skin color 0 Light Red 1 Red 2 Dark Red/purple 3 Size None 0 Small (\< 5mm) 1 Large (\> 5mm) 2 Confluent 3 Extension \<50 % cheek surface 2 \>50% cheek surface 3 |
| Secondary | Subjective (Participant or Parent/Caregiver) Percentage Change Rating Scale | After 26 weeks treatment | Percentage change in facial angiofibroma since beginning treatment, as assessed by the participant or parent/caregiver. A large value indicates most improvement to facial angiofibroma (minimum=0, maximum=100). This was a single assessment time-point, where the participant or parent/caregiver estimated the percentage change in the facial angiofibroma lesion appearance from their perspective since baseline. |
| Secondary | Objective (Clinician) Percentage Change Rating Scale | After 26 weeks treatment | Percentage improvement in facial angiofibroma since beginning treatment, as assessed by the clinician. A large value indicates most improvement to facial angiofibroma (minimum=0, maximum=100). This was a single assessment time-point, where clinicians estimated the percentage change in the facial angiofibroma lesion appearance from their perspective since baseline. |
| Secondary | Categorical Change in Facial Angiofibroma | After 26 weeks treatment | Change in facial angiofibroma since beginning treatment on a 5-point scale, as assessed by the participant or parent/caregiver. This was a single assessment time-point, where the participant or parent/caregiver evaluated the change in the facial angiofibroma lesion appearance from their perspective since baseline. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Obtaining Successful Treatment | After 26 weeks treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Treatment Success | From first dose to 26 weeks (± 2 weeks) | weeks | MEAN | |
| SECONDARY | Change From Baseline in Investigator's Global Assessment | At baseline and after 26 weeks treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change From Baseline in Facial Angiofibroma Severity Index (FASI) | At baseline and after 26 weeks treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Subjective (Participant or Parent/Caregiver) Percentage Change Rating Scale | After 26 weeks treatment | Percentage Change | MEAN | |
| SECONDARY | Objective (Clinician) Percentage Change Rating Scale | After 26 weeks treatment | Percentage Change | MEAN | |
| SECONDARY | Categorical Change in Facial Angiofibroma | After 26 weeks treatment | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Obtaining Successful Treatment | 0.5% Rapamycin Cream, Topical | 4 | Participants | ||
| Percentage of Participants Obtaining Successful Treatment | 1.0% Rapamycin Cream, Topical | 3 | Participants | ||
| Percentage of Participants Obtaining Successful Treatment | Placebo | 2 | Participants | ||
| Time to Treatment Success | 0.5% Rapamycin Cream, Topical | 25.89 | Standard Error 0.7 | weeks | |
| Time to Treatment Success | 1.0% Rapamycin Cream, Topical | 26.71 | Standard Error 0.28 | weeks | |
| Time to Treatment Success | Placebo | 19.7 | Standard Error 0.22 | weeks | |
| Change From Baseline in Investigator's Global Assessment | 0.5% Rapamycin Cream, Topical | -2 | 4 | Participants | |
| Change From Baseline in Investigator's Global Assessment | 1.0% Rapamycin Cream, Topical | -2 | 3 | Participants | |
| Change From Baseline in Investigator's Global Assessment | Placebo | -2 | 2 | Participants | |
| Change From Baseline in Investigator's Global Assessment | 0.5% Rapamycin Cream, Topical | -1 | 16 | Participants |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 0.5% Rapamycin Cream, Topical | 36 | |
| Overall Study | STARTED | 1.0% Rapamycin Cream, Topical | 33 | |
| Overall Study | STARTED | Placebo | 38 | |
| Overall Study | COMPLETED | 0.5% Rapamycin Cream, Topical | 32 | |
| Overall Study | COMPLETED | 1.0% Rapamycin Cream, Topical | 31 | |
| Overall Study | COMPLETED | Placebo | 35 | |
| Overall Study | NOT COMPLETED | 0.5% Rapamycin Cream, Topical | 4 | |
| Overall Study | NOT COMPLETED | 1.0% Rapamycin Cream, Topical | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 3 |
Source ClinicalTrials.gov
Adverse events90
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Skin burning sensation | Skin and subcutaneous tissue disorders | 0.5% Rapamycin Cream, Topical | 13 | 36 | 15 |
| other | Skin burning sensation | Skin and subcutaneous tissue disorders | 1.0% Rapamycin Cream, Topical | 6 | 33 | 7 |
| other | Skin burning sensation | Skin and subcutaneous tissue disorders | Placebo | 5 | 38 | 5 |
| other | Pruritus | Skin and subcutaneous tissue disorders | 0.5% Rapamycin Cream, Topical | 9 | 36 | 9 |
| other | Pruritus | Skin and subcutaneous tissue disorders | 1.0% Rapamycin Cream, Topical | 12 | 33 | 13 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Placebo | 2 | 38 | 2 |
| other | Erythema | Skin and subcutaneous tissue disorders | 0.5% Rapamycin Cream, Topical | 7 | 36 | 7 |
| other | Erythema | Skin and subcutaneous tissue disorders | 1.0% Rapamycin Cream, Topical | 6 | 33 | 7 |
| other | Erythema | Skin and subcutaneous tissue disorders | Placebo | 4 | 38 | 5 |
| other | Dry Skin | Skin and subcutaneous tissue disorders | 0.5% Rapamycin Cream, Topical | 7 | 36 | 7 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 0.5% Rapamycin Cream, Topical | 0 | 36 |
| Total, all-cause mortality | 1.0% Rapamycin Cream, Topical | 0 | 33 |
| Total, all-cause mortality | Placebo | 0 | 38 |
| Total, other adverse events | 0.5% Rapamycin Cream, Topical | 29 | 36 |
| Total, other adverse events | 1.0% Rapamycin Cream, Topical | 27 | 33 |
| Total, other adverse events | Placebo | 27 | 38 |
| Total, serious adverse events | 0.5% Rapamycin Cream, Topical | 2 | 36 |
| Total, serious adverse events | 1.0% Rapamycin Cream, Topical | 2 | 33 |
| Total, serious adverse events | Placebo | 2 | 38 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37463422 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03826628
GET https://conductscience.org/api/trials/v1/NCT03826628/results?page=2