Trial · NCT03791060
Secukinumab for NLD (Cosentyx) in Patients With Necrobiosis Lipoidica Diabeticorum (NLD)
NCT03791060, Phase 2, Terminated, Beth Israel Deaconess Medical Center; results first posted 2024-05-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Secukinumab for NLD (Cosentyx) in Patients With Necrobiosis Lipoidica Diabeticorum (NLD). Trials, record NCT03791060. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03791060
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Secukinumab for NLD (Cosentyx) in Patients With Necrobiosis Lipoidica Diabeticorum (NLD)
- NCT number
- NCT03791060
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 4 participants, actual
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Conditions
- Necrobiosis Lipoidica Diabeticorum
- Interventions
- Secukinumab
- First posted
- 2019-01-02
- Last updated
- 2024-05-17
- Results first posted
- 2024-05-17
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Score of Participants Who Received Investigator Global Assessment Scores | 24 weeks | Number of patients who received Investigator Global Assessment Scores rating their remission or clinical improvement as measured at week 24. The minimum score is zero and the maximum score is 6. A larger score is worse. Score Descriptions: 0\. Completely clear: except for possible residual hyperpigmentation 1. Almost clear: very significant clearance (about 90%); however, patchy remnants of dusky erythema and/or very small ulcerations 2. Marked improvement: significant improvement (about 75%); however, a small amount of disease remaining (i.e. remaining ulcers, although have decreased in size, minimal erythema and/or active boarder) 3. Moderate improvement: intermediate between slight and marked; representing about 50% improvement 4. Slight improvement: some improvement (about 25%); however, significant disease remaining (i.e. remaining ulcers with only minor decrease in size, erythema or boarder activity) 5. No change from baseline 6. Worse |
| Secondary | Histology | 26 weeks | Number of subjects achieving improvement based upon histological score. The score is calculated by adding subscores as listed below, which will be evaluated by the dermatopathologist. Average of pre and post scores and overall change in score will be calculated and compared using a paired T-test. 1. Inflammatory infiltrate (0, none; 1, slight; 2, moderate; 3, severe) 2. collagen degeneration (0, none; 1, slight; 2, moderate; 3, severe) 3. epithelioid histiocytes, (0, none; 1, slight; 2, moderate; 3, severe) 4. qualitative expression of IL-17 (0, none; 1, slight; 2 moderate; 3, severe) Histologic analysis not performed as study was terminated prematurely. |
| Secondary | Pain Score Baseline and Week 24 | Baseline and Week 24 | Number of patients who completed the self-reported pain and stinging intensity during and directly after treatment with Secukinumab injections A Pain Score will be calculated based upon the Wong-Baker Faces Pain rating Scale (10-point pain score), which has been widely used to rate pain in both children and adults and has also been used in dermatology clinical trials. Scale score 0-10, higher score means worse outcome: 0 = No hurt 2 = Hurts a little bit 4 = Hurts a little bit more 6 = Hurts even more 8 = Hurts whole lot 10 = Hurts worst Response based on an improvement from baseline in the Wong-Baker pain score at all scheduled time points will be calculated. We will compare pre and post treatment pain values and categorize patients as (i) Resolved (ii) Improved (iii) Stable (iv) Worsened |
| Secondary | Dermatology Life Quality Index | Baseline and Week 24 | Number of subjects improving based upon patient-reported outcomes The Dermatology Life Quality Index (DLQI) is a validated general dermatology questionnaire that consists of 10 items that assess subject health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment) The scoring of each question is as follows: Very much scored = 3 points, A lot scored = 2 points, A little scored = 1, Not at all scored = 0 points, Not relevant scored = 0 points, Question 7, 'prevented work or studying' scored = 3 points. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 (meaning maximum impact on quality of life) and a minimum of 0 (meaning no impact of skin disease on quality of life). The higher the score, the more quality of life is impaired. 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Score of Participants Who Received Investigator Global Assessment Scores | 24 weeks | score on a scale | MEAN | |
| SECONDARY | Histology | 26 weeks | Histologic analysis was not performed on any subjects. Study was terminated prematurely and performing histology analysis for 4 subjects would not have reflected appropriate results. Dermatopathologist didnt evaluate biopsies, only confirm diagnosis for eligibility. | ||
| SECONDARY | Pain Score Baseline and Week 24 | Baseline and Week 24 | Analyzed mean scores for Baseline and Week 24 | score on a scale | MEAN |
| SECONDARY | Dermatology Life Quality Index | Baseline and Week 24 | DLQI data analyzed for Baseline and Week 24 only | score on a scale | MEAN |
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 |
|---|---|---|---|---|---|
| Mean Score of Participants Who Received Investigator Global Assessment Scores | Secukinumab Subcutaneous Injection | 4 | Standard Deviation 0.81 | score on a scale | |
| Pain Score Baseline and Week 24 | Secukinumab Subcutaneous Injection | Week 1 | 1 | Standard Deviation 2 | score on a scale |
| Pain Score Baseline and Week 24 | Secukinumab Subcutaneous Injection | Week 24 | 1 | Standard Deviation 1.54 | score on a scale |
| Dermatology Life Quality Index | Secukinumab Subcutaneous Injection | Week 1 | 6.25 | Standard Deviation 4.43 | score on a scale |
| Dermatology Life Quality Index | Secukinumab Subcutaneous Injection | Week 24 | 3.25 | Standard Deviation 4.57 | score on a scale |
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 | Secukinumab Subcutaneous Injection | 4 | |
| Overall Study | COMPLETED | Secukinumab Subcutaneous Injection | 3 | |
| Overall Study | NOT COMPLETED | Secukinumab Subcutaneous Injection | 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 | Secukinumab Subcutaneous Injection | 0 | 4 |
| Total, other adverse events | Secukinumab Subcutaneous Injection | 0 | 4 |
| Total, serious adverse events | Secukinumab Subcutaneous Injection | 0 | 4 |
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/NCT03791060
GET https://conductscience.org/api/trials/v1/NCT03791060/registered