Trial · NCT06476366
Comparison of Efficacy of Methotrexate and Azathioprine in Patients With Chronic Actinic Dermatitis: A Randomized Controlled Trial
NCT06476366, Early phase 1, Completed, Pak Emirates Military Hospital; results first posted 2025-08-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison of Efficacy of Methotrexate and Azathioprine in Patients With Chronic Actinic Dermatitis: A Randomized Controlled Trial. Trials, record NCT06476366. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06476366
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Efficacy of Methotrexate and Azathioprine in Patients With Chronic Actinic Dermatitis: A Randomized Controlled Trial
- NCT number
- NCT06476366
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 50 participants, actual
- Lead sponsor
- Pak Emirates Military Hospital
- Conditions
- Chronic Actinic Dermatitis
- Interventions
- Azathioprine, Methotrexate
- First posted
- 2024-06-26
- Last updated
- 2026-05-11
- Results first posted
- 2025-08-17
- Limitations and caveats
- Lower than expected sample size may impact on the generalizability of results
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 50% Reduction in the Eczema Area and Severity Index Score (EASI-50) | 6 months | EASI-50 means 50% reduction in the Eczema Area and Severity Index score from baseline score. EASI is a scale used to evaluate the degree and severity of eczema. The total EASI score is between 0 and 72 . Mild disease: Patients with a score of 1.1-7.0 on the EASI scale will be classified as having mild disease. Moderate disease: Patients with a score of 7.1 to 21.0 on the EASI scale will be classified as having moderate disease. Severe disease: Patients with a score of 21.1-50.0 on the EASI scale will be classified as having severe disease. Very Severe disease: Patients with a score of 50.1-72.0 on the EASI scale will be classified as having very severe disease. |
| Secondary | Investigator Global Assessment (IGA) Score of 0-2 | 6 months | Investigator global assessment (IGA) is a subjective measure of disease severity which is assessed by the physician on patient's visit. It ranges from 0 to 4 (0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe) |
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 | 50% Reduction in the Eczema Area and Severity Index Score (EASI-50) | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Investigator Global Assessment (IGA) Score of 0-2 | 6 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 50% Reduction in the Eczema Area and Severity Index Score (EASI-50) | Methotrexate Arm | 3 | Participants | ||
| 50% Reduction in the Eczema Area and Severity Index Score (EASI-50) | Azathioprine | 2 | Participants | ||
| Investigator Global Assessment (IGA) Score of 0-2 | Methotrexate Arm | 5 | Participants | ||
| Investigator Global Assessment (IGA) Score of 0-2 | Azathioprine | 3 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Methotrexate Arm | 10 | |
| Overall Study | STARTED | Azathioprine | 10 | |
| Overall Study | COMPLETED | Methotrexate Arm | 8 | |
| Overall Study | COMPLETED | Azathioprine | 7 | |
| Overall Study | NOT COMPLETED | Methotrexate Arm | 2 | |
| Overall Study | NOT COMPLETED | Azathioprine | 3 |
Source ClinicalTrials.gov
Adverse events6
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 | Body aches and myalgias | Musculoskeletal and connective tissue disorders | Methotrexate Arm | 1 | 10 | |
| other | Body aches and myalgias | Musculoskeletal and connective tissue disorders | Azathioprine | 2 | 10 | |
| other | Gastritis, nausea, vomiting | Gastrointestinal disorders | Methotrexate Arm | 0 | 10 | |
| other | Gastritis, nausea, vomiting | Gastrointestinal disorders | Azathioprine | 1 | 10 | |
| serious | Anemia/pancytopenia during treatment | Blood and lymphatic system disorders | Methotrexate Arm | 1 | 10 | 1 |
| serious | Anemia/pancytopenia during treatment | Blood and lymphatic system disorders | Azathioprine | 0 | 10 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Methotrexate Arm | 0 | 10 |
| Total, all-cause mortality | Azathioprine | 0 | 10 |
| Total, other adverse events | Methotrexate Arm | 1 | 10 |
| Total, other adverse events | Azathioprine | 3 | 10 |
| Total, serious adverse events | Methotrexate Arm | 1 | 10 |
| Total, serious adverse events | Azathioprine | 0 | 10 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Methotrexate Arm vs Azathioprine: Investigator Global Assessment (IGA) Score of 0-2 | Trial comparisons |
| Methotrexate Arm vs Azathioprine: 50% Reduction in the Eczema Area and Severity Index Score (EASI-50) | Trial comparisons |
| Methotrexate Arm vs Azathioprine: deaths from any cause | Trial comparisons |
| Methotrexate Arm vs Azathioprine: serious adverse events | Trial comparisons |
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/NCT06476366
GET https://conductscience.org/api/trials/v1/NCT06476366/registered