Trial · NCT05332366
A Trial to Assess the Effect of Delgocitinib Cream 20 mg/g on the Molecular Signature, Safety, and Efficacy in Adults With Frontal Fibrosing Alopecia
NCT05332366, Phase 2, Completed, LEO Pharma; results first posted 2025-02-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Trial to Assess the Effect of Delgocitinib Cream 20 mg/g on the Molecular Signature, Safety, and Efficacy in Adults With Frontal Fibrosing Alopecia. Trials, record NCT05332366. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05332366
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial to Assess the Effect of Delgocitinib Cream 20 mg/g on the Molecular Signature, Safety, and Efficacy in Adults With Frontal Fibrosing Alopecia
- NCT number
- NCT05332366
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 35 participants, actual
- Lead sponsor
- LEO Pharma
- Conditions
- Frontal Fibrosing Alopecia
- Interventions
- Delgocitinib cream, Delgocitinib cream vehicle
- First posted
- 2022-04-18
- Last updated
- 2025-03-06
- Results first posted
- 2025-02-07
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Expression of Chemokine (C-X-C Motif) Ligand 9 (CXCL9), Chemokine (C-X-C Motif) Ligand 10 (CXCL10), and Interferon (IFN)-γ From Baseline to Week 12. | Baseline and Week 12 | CXCL9, CXCL10 and IFN-γ are small proteins that act as chemical messengers, especially in the immune system. |
| Secondary | Number of Treatment-emergent Adverse Events (TEAEs) From Baseline to Week 12. | Between baseline and Week 12 | Treatment emergent adverse events (TEAEs) were defined as any AEs with onset date on or after the first study treatment dosing. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Expression of Chemokine (C-X-C Motif) Ligand 9 (CXCL9), Chemokine (C-X-C Motif) Ligand 10 (CXCL10), and Interferon (IFN)-γ From Baseline to Week 12. | Baseline and Week 12 | No data was collected for No Treatment Arm/Groups. | Fold-changes | NUMBER |
| SECONDARY | Number of Treatment-emergent Adverse Events (TEAEs) From Baseline to Week 12. | Between baseline and Week 12 | No investigational product was administered in Cohort 2 No Treatment Arm/Groups and thereby were no treatment-emergent AESIs reported in this trial for No Treatment Arm/Groups. | events | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Expression of Chemokine (C-X-C Motif) Ligand 9 (CXCL9), Chemokine (C-X-C Motif) Ligand 10 (CXCL10), and Interferon (IFN)-γ From Baseline to Week 12. | Delgocitinib - Delgocitinib | (C-X-C motif) ligand 9 (CXCL9) | -3.10 | Fold-changes | |
| Change in Expression of Chemokine (C-X-C Motif) Ligand 9 (CXCL9), Chemokine (C-X-C Motif) Ligand 10 (CXCL10), and Interferon (IFN)-γ From Baseline to Week 12. | Placebo - Delgocitinib | (C-X-C motif) ligand 9 (CXCL9) | -1.12 | Fold-changes | |
| Change in Expression of Chemokine (C-X-C Motif) Ligand 9 (CXCL9), Chemokine (C-X-C Motif) Ligand 10 (CXCL10), and Interferon (IFN)-γ From Baseline to Week 12. | Delgocitinib - Delgocitinib | Chemokine (C-X-C motif) ligand 10 (CXCL10) | -2.60 | Fold-changes | |
| Change in Expression of Chemokine (C-X-C Motif) Ligand 9 (CXCL9), Chemokine (C-X-C Motif) Ligand 10 (CXCL10), and Interferon (IFN)-γ From Baseline to Week 12. | Placebo - Delgocitinib | Chemokine (C-X-C motif) ligand 10 (CXCL10) | -1.10 | Fold-changes | |
| Change in Expression of Chemokine (C-X-C Motif) Ligand 9 (CXCL9), Chemokine (C-X-C Motif) Ligand 10 (CXCL10), and Interferon (IFN)-γ From Baseline to Week 12. | Delgocitinib - Delgocitinib | Interferon (IFN)-γ | -1.49 | Fold-changes | |
| Change in Expression of Chemokine (C-X-C Motif) Ligand 9 (CXCL9), Chemokine (C-X-C Motif) Ligand 10 (CXCL10), and Interferon (IFN)-γ From Baseline to Week 12. | Placebo - Delgocitinib | Interferon (IFN)-γ | -1.097 | Fold-changes | |
| Number of Treatment-emergent Adverse Events (TEAEs) From Baseline to Week 12. | Delgocitinib - Delgocitinib | 4 | events | ||
| Number of Treatment-emergent Adverse Events (TEAEs) From Baseline to Week 12. | Placebo - Delgocitinib | 9 | events |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Delgocitinib - Delgocitinib | 15 | |
| Overall Study | STARTED | Placebo - Delgocitinib | 15 | |
| Overall Study | STARTED | No Treatment | 5 | |
| Overall Study | COMPLETED | Delgocitinib - Delgocitinib | 15 | |
| Overall Study | COMPLETED | Placebo - Delgocitinib | 15 | |
| Overall Study | COMPLETED | No Treatment | 5 | |
| Overall Study | NOT COMPLETED | Delgocitinib - Delgocitinib | 0 | |
| Overall Study | NOT COMPLETED | Placebo - Delgocitinib | 0 | |
| Overall Study | NOT COMPLETED | No Treatment | 0 |
Source ClinicalTrials.gov
Adverse events54
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 | Pain | General disorders | Delgocitinib - Delgocitinib | 1 | 15 | 1 |
| other | Pain | General disorders | Placebo - Delgocitinib | 0 | 15 | 0 |
| other | Pain | General disorders | No Treatment | 0 | 0 | 0 |
| other | COVID-19 | Infections and infestations | Delgocitinib - Delgocitinib | 1 | 15 | 1 |
| other | COVID-19 | Infections and infestations | Placebo - Delgocitinib | 7 | 15 | 7 |
| other | COVID-19 | Infections and infestations | No Treatment | 0 | 0 | 0 |
| other | Pneumonia | Infections and infestations | Delgocitinib - Delgocitinib | 0 | 15 | 0 |
| other | Pneumonia | Infections and infestations | Placebo - Delgocitinib | 1 | 15 | 1 |
| other | Pneumonia | Infections and infestations | No Treatment | 0 | 0 | 0 |
| other | Upper respiratory tract infection | Infections and infestations | Delgocitinib - Delgocitinib | 0 | 15 | 0 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Delgocitinib - Delgocitinib | 0 | 15 |
| Total, all-cause mortality | Placebo - Delgocitinib | 0 | 15 |
| Total, all-cause mortality | No Treatment | 0 | 0 |
| Total, other adverse events | Delgocitinib - Delgocitinib | 6 | 15 |
| Total, other adverse events | Placebo - Delgocitinib | 10 | 15 |
| Total, other adverse events | No Treatment | 0 | 0 |
| Total, serious adverse events | Delgocitinib - Delgocitinib | 0 | 15 |
| Total, serious adverse events | Placebo - Delgocitinib | 0 | 15 |
| Total, serious adverse events | No Treatment | 0 | 0 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41101628 | DERIVED |
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/NCT05332366
GET https://conductscience.org/api/trials/v1/NCT05332366/events?page=2