Trial · NCT00168064
Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides
NCT00168064, Phase 2, Completed, Yaupon Therapeutics; results first posted 2012-10-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides. Trials, record NCT00168064. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00168064
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides
- NCT number
- NCT00168064
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 260 participants, actual
- Lead sponsor
- Yaupon Therapeutics
- Conditions
- Mycosis Fungoides
- Interventions
- mechlorethamine-MCH (nitrogen mustard)
- First posted
- 2005-09-14
- Last updated
- 2012-10-31
- Results first posted
- 2012-10-31
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ratio of Response Rates Based on CAILS | Assessment made at Day 1 and every subsequent visit during treatment | The ratio of the response rate of the patients treated with the PG formulation to the response rate of the patients treated with the AP formulation. Skin response determined by at least a 50% reduction from baseline in the Composite Assessment of Index Lesion Severity (CAILS) following up to 12 months of treatment |
| Secondary | Severity-weighted Assessment Tool (SWAT) Within up to 12 Months by 2 or More Consecutive Observations Over at Least 4 Weeks | Assessment made at Day 1 and every subsequent visit during treatment | |
| Secondary | Percent of Participants Achieving at Least 50% Improvement of Severity Weighted Assessment Tool (SWAT) | Baseline to end of therapy | Assessment of lesion distribution and severity. A responder analysis was performed on whether subject achieved at least 50% improvement on scale. This had to be confirmed on at least one visit at least 4 weeks apart. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Ratio of Response Rates Based on CAILS | Assessment made at Day 1 and every subsequent visit during treatment | ITT | percentage of participants | NUMBER |
| SECONDARY | Severity-weighted Assessment Tool (SWAT) Within up to 12 Months by 2 or More Consecutive Observations Over at Least 4 Weeks | Assessment made at Day 1 and every subsequent visit during treatment | |||
| SECONDARY | Percent of Participants Achieving at Least 50% Improvement of Severity Weighted Assessment Tool (SWAT) | Baseline to end of therapy | Percent of participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Ratio of Response Rates Based on CAILS | PG- Mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel | 76 | percentage of participants | ||
| Ratio of Response Rates Based on CAILS | AP- Aquaphor Formulation Mechlorethamine-MCH (NM) 0.02% | 62 | percentage of participants | ||
| Percent of Participants Achieving at Least 50% Improvement of Severity Weighted Assessment Tool (SWAT) | PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel | 61 | Percent of participants | ||
| Percent of Participants Achieving at Least 50% Improvement of Severity Weighted Assessment Tool (SWAT) | AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor | 60 | Percent of 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 | PG -Mechlorethamine (Nitrogen Mustard) 0.02% PG Gel | 130 | |
| Overall Study | STARTED | AP- Mechlorethamine 0.02% Compounded in Aquaphor | 130 | |
| Overall Study | COMPLETED | PG -Mechlorethamine (Nitrogen Mustard) 0.02% PG Gel | 81 | |
| Overall Study | COMPLETED | AP- Mechlorethamine 0.02% Compounded in Aquaphor | 86 | |
| Overall Study | NOT COMPLETED | PG -Mechlorethamine (Nitrogen Mustard) 0.02% PG Gel | 49 | |
| Overall Study | NOT COMPLETED | AP- Mechlorethamine 0.02% Compounded in Aquaphor | 44 |
Source ClinicalTrials.gov
Adverse events14
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 irritation | Skin and subcutaneous tissue disorders | PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel | 32 | 128 | 32 |
| other | skin irritation | Skin and subcutaneous tissue disorders | AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor | 18 | 127 | 18 |
| other | pruritus | Skin and subcutaneous tissue disorders | PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel | 25 | 128 | 25 |
| other | pruritus | Skin and subcutaneous tissue disorders | AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor | 20 | 127 | 20 |
| other | erythema | Skin and subcutaneous tissue disorders | PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel | 22 | 128 | 22 |
| other | erythema | Skin and subcutaneous tissue disorders | AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor | 18 | 127 | 18 |
| other | dermatitis contact | Skin and subcutaneous tissue disorders | PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel | 19 | 128 | 19 |
| other | dermatitis contact | Skin and subcutaneous tissue disorders | AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor | 19 | 127 | 19 |
| other | skin hyperpigmentation | Skin and subcutaneous tissue disorders | PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel | 7 | 128 | 7 |
| other | skin hyperpigmentation | Skin and subcutaneous tissue disorders | AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor | 9 | 127 | 9 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel | ||
| Total, all-cause mortality | AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor | ||
| Total, other adverse events | PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel | 108 | 128 |
| Total, other adverse events | AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor | 99 | 127 |
| Total, serious adverse events | PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel | 0 | 128 |
| Total, serious adverse events | AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor | 0 | 127 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel vs AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor: serious adverse events |
Source 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/NCT00168064
GET https://conductscience.org/api/trials/v1/NCT00168064/registered