Trial · NCT02165605
HylaCare in the Treatment of Acute Skin Changes in Patients Undergoing Radiotherapy for Breast Cancer
NCT02165605, Not applicable, Completed, University of Texas Southwestern Medical Center; results first posted 2020-10-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. HylaCare in the Treatment of Acute Skin Changes in Patients Undergoing Radiotherapy for Breast Cancer. Trials, record NCT02165605. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02165605
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- HylaCare in the Treatment of Acute Skin Changes in Patients Undergoing Radiotherapy for Breast Cancer
- NCT number
- NCT02165605
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 28 participants, actual
- Lead sponsor
- University of Texas Southwestern Medical Center
- Conditions
- Breast Cancer
- Interventions
- HylaCare, Placebo
- First posted
- 2014-06-17
- Last updated
- 2020-10-22
- Results first posted
- 2020-10-22
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Acute Skin Toxicity Per NCI-CTC v4.0 | Week 5 during radiation therapy | NCI-CTC (National Cancer Institute-Common Terminology Criteria) version 4.0 was used to assessed acute skin toxicity grade by physician. Toxicity grade range from Grade 0 to Grade 5, with higher grade indicating worst skin toxicity. |
| Primary | Acute Skin Toxicity Per NCI-CTC v4.0 | Week 2 post-radiation therapy | NCI-CTC(National Cancer Institute-Common Terminology Criteria) version 4.0 was used to assessed acute skin toxicity grade by physician. Toxicity grade range from Grade 0 to Grade 5, with higher grade indicating worst skin toxicity. |
| Primary | Acute Skin Toxicity Per Investigator Grading Scale | Week 5 during radiation therapy | Investigator Grading Scale is used to assessed acute skin toxicity. Score range from grade 0 to 6 with 0 = normal skin 1. = light epidermal irritation, consisting of the onset of erythema, possibly associated with slight edema 2. = erythema with dry desquamation 3. = wet desquamation \</= 2 cm 4. = wet desquamation from 2.1 - 5cm 5. = wet desquamation from 5.1 - 9 cm 6. = wet desquamation \> 9.1 cm |
| Primary | Acute Skin Toxicity Per Investigator Grading Scale | Week 2 post-radiation therapy | Investigator Grading Scale is used to assessed acute skin toxicity. Score range from grade 0 to 6 with 0 = normal skin 1. = light epidermal irritation, consisting of the onset of erythema, possibly associated with slight edema 2. = erythema with dry desquamation 3. = wet desquamation \</= 2 cm 4. = wet desquamation from 2.1 - 5cm 5. = wet desquamation from 5.1 - 9 cm 6. = wet desquamation \> 9.1 cm |
| Secondary | Acute Skin Toxicity, as Measured by Number of Participants With Skin Reactions | Week 5 during radiation therapy | Acute skin toxicity, as measured by number of participants with skin reactions via self assessment |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Acute Skin Toxicity Per NCI-CTC v4.0 | Week 5 during radiation therapy | All 28 patients were assigned to both arms HA formulation (Hylacare study cream) on the medial or lateral half of the irradiated breast and the control cream (placebo) on the other half. Each patient will use both HA study cream and placebo cream on breast receiving radiation treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Acute Skin Toxicity Per NCI-CTC v4.0 | Week 2 post-radiation therapy | We only analyze available data | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Acute Skin Toxicity Per Investigator Grading Scale | Week 5 during radiation therapy | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Acute Skin Toxicity Per Investigator Grading Scale | Week 2 post-radiation therapy | We only analyzed data that were available | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Acute Skin Toxicity, as Measured by Number of Participants With Skin Reactions | Week 5 during radiation therapy | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Acute Skin Toxicity Per NCI-CTC v4.0 | HylaCare | Grade 0 | 3 | Participants | |
| Acute Skin Toxicity Per NCI-CTC v4.0 | Placebo | Grade 0 | 3 | Participants | |
| Acute Skin Toxicity Per NCI-CTC v4.0 | HylaCare | Grade 1 | 19 | Participants | |
| Acute Skin Toxicity Per NCI-CTC v4.0 | Placebo | Grade 1 | 18 | Participants | |
| Acute Skin Toxicity Per NCI-CTC v4.0 | HylaCare | Grade 2 | 6 | Participants | |
| Acute Skin Toxicity Per NCI-CTC v4.0 | Placebo | Grade 2 | 7 | Participants | |
| Acute Skin Toxicity Per NCI-CTC v4.0 | HylaCare | Grade ≥3 | 0 | Participants | |
| Acute Skin Toxicity Per NCI-CTC v4.0 | Placebo | Grade ≥3 | 0 | Participants | |
| Acute Skin Toxicity Per NCI-CTC v4.0 | HylaCare | Grade 0 | 5 | Participants | |
| Acute Skin Toxicity Per NCI-CTC v4.0 | Placebo | Grade 0 | 3 | Participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | HA Serum Vs. Control Cream (Placebo) | 28 | |
| Overall Study | COMPLETED | HA Serum Vs. Control Cream (Placebo) | 28 | |
| Overall Study | NOT COMPLETED | HA Serum Vs. Control Cream (Placebo) | 0 |
Source ClinicalTrials.gov
Adverse events1
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 | Desquamation | Skin and subcutaneous tissue disorders | Expected Adverse Events With and Without Skin Cream(Hylacare) | 14 | 28 | 14 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Expected Adverse Events With and Without Skin Cream(Hylacare) | 0 | 28 |
| Total, other adverse events | Expected Adverse Events With and Without Skin Cream(Hylacare) | 14 | 28 |
| Total, serious adverse events | Expected Adverse Events With and Without Skin Cream(Hylacare) | 0 | 28 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31273506 | 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/NCT02165605
GET https://conductscience.org/api/trials/v1/NCT02165605/results?page=2