Trial · NCT01676831
Topical Resiquimod for the Treatment of Early Stage Cutaneous T Cell Lymphoma (CTCL)
NCT01676831, Phase 1, Phase 2, Completed, Abramson Cancer Center at Penn Medicine; results first posted 2019-08-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Topical Resiquimod for the Treatment of Early Stage Cutaneous T Cell Lymphoma (CTCL). Trials, record NCT01676831. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01676831
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Topical Resiquimod for the Treatment of Early Stage Cutaneous T Cell Lymphoma (CTCL)
- NCT number
- NCT01676831
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Conditions
- Cutaneous T Cell Lymphoma
- Interventions
- Topical resiquimod 0.06%, topical resiquimod 0.03%
- First posted
- 2012-08-31
- Last updated
- 2019-08-13
- Results first posted
- 2019-08-13
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Number of Participants That Tolerated the Maximum Drug Dose | after 4 subjects have completed 4 weeks of study drug | After four subjects have completed at least four weeks of study drug dosing a safety review meeting will be conducted by a safety review committee. No subjects will be enrolled in the next concentration (0.03%)group until all eight have been evaluated in the 0.06% group. The safety review committee reviews all patient data including adverse events to indicate whether the patient can escalate to the highest dose. |
| Secondary | Secondary End Points: Efficacy- CAILDS SCORE | Up to 24 weeks or At the conclusion of patient therapy | The secondary endpoint is: • The Response Rate (Complete or Partial Response) based on Composite Assessment of Index Lesions Disease Severity (CAILDS) score at EOS for the baseline target lesions. Complete Response is defined as a score of '0' on the CAILDS scale. Partial response is defined as a reduction of at least 50% in the CAILDS. The outcome measure will indicate how many received complete response (CR), partial response (PR), and stable disease (SD). |
| Secondary | Secondary End Points: Efficacy- SWAT SCORE | Up to 24 weeks or At the conclusion of patient therapy | The secondary endpoint is: The total surface area of involvement will also be assessed (SWAT score). A partial response will represent improvement in 50% or greater of the skin surface area with regression of lesions. A complete response will represent complete clear clearing of skin lesions and in the case of stage IIA patients, resolution of lymphadenopathy. The outcome measure will indicate how many received complete response (CR), partial response (PR), and stable disease (SD). |
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 | The Number of Participants That Tolerated the Maximum Drug Dose | after 4 subjects have completed 4 weeks of study drug | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Secondary End Points: Efficacy- CAILDS SCORE | Up to 24 weeks or At the conclusion of patient therapy | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Secondary End Points: Efficacy- SWAT SCORE | Up to 24 weeks or At the conclusion of patient therapy | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Number of Participants That Tolerated the Maximum Drug Dose | Topical Resiquimod 0.06% | 8 | Participants | ||
| The Number of Participants That Tolerated the Maximum Drug Dose | Topical Resiquimod 0.03% | 4 | Participants | ||
| Secondary End Points: Efficacy- CAILDS SCORE | Topical Resiquimod 0.06% | Complete Response (CR) | 4 | Participants | |
| Secondary End Points: Efficacy- CAILDS SCORE | Topical Resiquimod 0.03% | Complete Response (CR) | 0 | Participants | |
| Secondary End Points: Efficacy- CAILDS SCORE | Topical Resiquimod 0.06% | Partial Response (PR) | 3 | Participants | |
| Secondary End Points: Efficacy- CAILDS SCORE | Topical Resiquimod 0.03% | Partial Response (PR) | 2 | Participants | |
| Secondary End Points: Efficacy- CAILDS SCORE | Topical Resiquimod 0.06% | Stable Disease (SD) | 1 | Participants | |
| Secondary End Points: Efficacy- CAILDS SCORE | Topical Resiquimod 0.03% | Stable Disease (SD) | 2 | Participants | |
| Secondary End Points: Efficacy- SWAT SCORE | Topical Resiquimod 0.06% | Complete Response (CR) | 2 | Participants | |
| Secondary End Points: Efficacy- SWAT SCORE | Topical Resiquimod 0.03% | Complete Response (CR) | 0 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Topical Resiquimod 0.06% | 8 | |
| Overall Study | STARTED | Topical Resiquimod 0.03% | 5 | |
| Overall Study | COMPLETED | Topical Resiquimod 0.06% | 8 | |
| Overall Study | COMPLETED | Topical Resiquimod 0.03% | 4 | |
| Overall Study | NOT COMPLETED | Topical Resiquimod 0.06% | 0 | |
| Overall Study | NOT COMPLETED | Topical Resiquimod 0.03% | 1 |
Source ClinicalTrials.gov
Adverse events10
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 | fever | Immune system disorders | Topical Resiquimod 0.06% | 2 | 8 | 2 |
| other | fever | Immune system disorders | Topical Resiquimod 0.03% | 0 | 5 | 0 |
| other | skin erosion | Skin and subcutaneous tissue disorders | Topical Resiquimod 0.06% | 4 | 8 | 4 |
| other | skin erosion | Skin and subcutaneous tissue disorders | Topical Resiquimod 0.03% | 0 | 5 | 0 |
| other | headache | General disorders | Topical Resiquimod 0.06% | 2 | 8 | 2 |
| other | headache | General disorders | Topical Resiquimod 0.03% | 0 | 5 | 0 |
| other | skin irritation | Skin and subcutaneous tissue disorders | Topical Resiquimod 0.06% | 1 | 8 | 1 |
| other | skin irritation | Skin and subcutaneous tissue disorders | Topical Resiquimod 0.03% | 2 | 5 | 2 |
| other | myalgia | General disorders | Topical Resiquimod 0.06% | 1 | 8 | 1 |
| other | myalgia | General disorders | Topical Resiquimod 0.03% | 0 | 5 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Topical Resiquimod 0.06% | 0 | 8 |
| Total, all-cause mortality | Topical Resiquimod 0.03% | 0 | 5 |
| Total, other adverse events | Topical Resiquimod 0.06% | 6 | 8 |
| Total, other adverse events | Topical Resiquimod 0.03% | 2 | 5 |
| Total, serious adverse events | Topical Resiquimod 0.06% | 0 | 8 |
| Total, serious adverse events | Topical Resiquimod 0.03% | 0 | 5 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26228486 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01FD004092 | Phase 1 Study of Resiquimod Gel Therapy for Cutaneous T-Cell Lymphoma | ROOK, ALAIN H; GELFAND, JOEL M | UNIVERSITY OF PENNSYLVANIA | FOOD AND DRUG ADMINISTRATION | 2012 to 2013 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Topical Resiquimod 0.06% vs Topical Resiquimod 0.03%: The Number of Participants That Tolerated the Maximum Drug Dose | Trial comparisons |
| Topical Resiquimod 0.06% vs Topical Resiquimod 0.03%: deaths from any cause | Trial comparisons |
| Topical Resiquimod 0.06% vs Topical Resiquimod 0.03%: 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/NCT01676831
GET https://conductscience.org/api/trials/v1/NCT01676831/registered