Trial · NCT03351114
Pilot Study Evaluating the Efficacy of a Topical PDE4 Inhibitor for Morphea
NCT03351114, Phase 2, Completed, Duke University; results first posted 2021-04-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pilot Study Evaluating the Efficacy of a Topical PDE4 Inhibitor for Morphea. Trials, record NCT03351114. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03351114
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pilot Study Evaluating the Efficacy of a Topical PDE4 Inhibitor for Morphea
- NCT number
- NCT03351114
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Morphea
- Interventions
- Crisaborole
- First posted
- 2017-11-22
- Last updated
- 2021-04-01
- Results first posted
- 2021-04-01
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Had a Reduction in Dermal Thickness of Sentinel Plaque | Baseline, 12 weeks | Change in dermal thickness on skin biopsy. A sentinel plaque will be selected at baseline. A 4 mm skin punch biopsy will be performed at baseline and at 12 weeks, on the same affected plaque. |
| Secondary | Percentage of Reduction in DIET Score of Sentinel Plaque | Baseline and 12 weeks | The DIET (Dyspigmentation, Induration, Erythema, and Telangiectasias) score is a physician-assessed, previously validated score. Range is 0-12, and a higher score denotes increased activity or severity. |
| Secondary | Percentage of Reduction in LoSCAT Score | Baseline,12 weeks | LoSCAT (Localized Scleroderma Cutaneous Assessment Tool ) score is a physician-assessed, previously validated score. It has 2 components, the LoSSI (localized scleroderma skin severity index, range 0-162), which measures disease activity, and LoSDI (localized scleroderma damage index, range 0-216). The higher the number, the higher the disease activity and damage, respectively. |
| Secondary | Percentage of Reduction in Skindex-29 Score | Baseline and 12 weeks | Skindex-29 is a health-related quality of life score; minimum score 30, maximum 150. Lower score indicates a better quality of life. |
| Secondary | Change in Dermal Thickness of Sentinel Plaque by Ultrasonography | Baseline, 4, 8 and 12 weeks, optional at 20 weeks | B-Mode ultrasonographic imaging will be utilized to measure dermal thickness of the sentinel plaque |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Had a Reduction in Dermal Thickness of Sentinel Plaque | Baseline, 12 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Reduction in DIET Score of Sentinel Plaque | Baseline and 12 weeks | percentage of reduction | MEAN | |
| SECONDARY | Percentage of Reduction in LoSCAT Score | Baseline,12 weeks | percentage of reduction | MEAN | |
| SECONDARY | Percentage of Reduction in Skindex-29 Score | Baseline and 12 weeks | percentage of reduction | MEAN | |
| SECONDARY | Change in Dermal Thickness of Sentinel Plaque by Ultrasonography | Baseline, 4, 8 and 12 weeks, optional at 20 weeks | Data not collected. |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Had a Reduction in Dermal Thickness of Sentinel Plaque | Crisaborole 2% Ointment | 5 | Participants | ||
| Percentage of Reduction in DIET Score of Sentinel Plaque | Crisaborole 2% Ointment | 33 | Standard Deviation 26 | percentage of reduction | |
| Percentage of Reduction in LoSCAT Score | Crisaborole 2% Ointment | LoSSI (Activity) | 37.5 | Standard Deviation 29 | percentage of reduction |
| Percentage of Reduction in LoSCAT Score | Crisaborole 2% Ointment | LoSDI (Damage) | 5 | Standard Deviation 36 | percentage of reduction |
| Percentage of Reduction in Skindex-29 Score | Crisaborole 2% Ointment | 25.7 | Standard Deviation 16.4 | percentage of reduction |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Crisaborole 2% Ointment | 8 | |
| Overall Study | COMPLETED | Crisaborole 2% Ointment | 7 | |
| Overall Study | NOT COMPLETED | Crisaborole 2% Ointment | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Crisaborole 2% Ointment | 0 | 8 |
| Total, other adverse events | Crisaborole 2% Ointment | 0 | 8 |
| Total, serious adverse events | Crisaborole 2% Ointment | 0 | 8 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT03351114
GET https://conductscience.org/api/trials/v1/NCT03351114/registered