Trial · NCT06801626
Novel Strategies for Reducing Burn Scar Itch
NCT06801626, Phase 3, Recruiting, The University of Texas Medical Branch, Galveston
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Novel Strategies for Reducing Burn Scar Itch. Trials, record NCT06801626. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06801626
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Novel Strategies for Reducing Burn Scar Itch
- NCT number
- NCT06801626
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 44 participants, estimated
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Conditions
- Burn Scar, Itch Scarring, Wound
- Interventions
- Famotidine and 4% topical cromolyn sodium, Placebo
- First posted
- 2025-01-30
- Last updated
- 2026-10-05
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Itch Scale: Visual Analogue Scale Itch (VAS Itch) | baseline, weekly for 3 months, at 3 and 6 months (+/-15 days each timepoint) after start date | Patients will score the severity of itch on the scale provided at study start, once weekly for 3 months, at the 3-month visit, and again at study end (6 months). Patients will rate their itch from 0 to 10. to measure the intensity of itchiness, where a patient marks a point on a line to indicate how severe their itch is, with zero representing "no itch" and 10 representing "worst imaginable itch." A higher score means a worse outcome. |
| Secondary | The Patient and Observer Scar Assessment Scale 3.0 | baseline, and at clinic visit approximately 3 months (±15 days) after study start | The Patient and Observer Scar Assessment Scale (POSAS) is an established scale for assessing scars by both the patient and the observer. The overall opinion of the scar is reported on a scale of 1-10, with 1 being normal skin and 10 being the worst scar. (POSAS 3.0) will be filled out by the participant and a clinical observer to evaluate scar severity/quality. |
| Secondary | Brisbane Burn Scar Impact Panel (BBSIP) | baseline, and at clinic visit approximately 3 months (±15 days) after study start | BBSIP is a patient-reported outcome measure developed in consultation with burn survivors that takes approximately 10 minutes to complete; the specificity of this comprehensive questionnaire allows detection of changes in quality of life related to burn hypertrophic scar. Higher scores indicate a worse outcome. |
| Secondary | PROMIS-29 | baseline, and at clinic visit approximately 3 months after study start (±15 days) | This questionnaire will be administered to determine whether the effects of treatment impact quality of life as reported by the patient. |
| Secondary | Pain scale: Visual Analog Scale for Pain (VAS Pain) | baseline, and at clinic visit approximately 3 months and 6 months after study start (±15 days) | The VAS pain score is a simple and effective method used to measure patients' pain levels. This method is typically represented by a line ranging from 0 to 10, where 0 indicates no pain and 10 indicates the most severe pain. Patients are asked to mark a point on the line that corresponds to their level of pain. |
| Secondary | Patient Global Impression of Change (PGIC) | baseline, and at clinic visit approximately 3 months after study start (±15 days) | A global index that consists of 3 questions to which participants will rate the severity of 1) their PAH symptoms, 2) shortness of breath (SOB), and 3) fatigue. The minimum and maximum range of scores for each of the 3 individual questions was 1-5, with severity scale choices of 1=not present, 2=mild, 3=moderate, 4=severe, and 5=very severe. A higher score indicates a worse outcome. |
| Secondary | Participants Activity with Fitbit | Month 1, 2, 3 (+15 days, each timepoint) | Overall activity: To be captured via Fitbit on a daily basis to gauge overall activity. These data will be correlated with the itch and pain scales, as reduced activity is associated with pain and/or itch. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
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 totals0
The totals the trial posted for each group.
None in this release.
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/NCT06801626
GET https://conductscience.org/api/trials/v1/NCT06801626/registered