An interventional study of Avena Sativa Skincare Regimen in Ichthyosis and Pruritus, sponsored by Johnson & Johnson Consumer Inc. (J&JCI). Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-11-04.
Sponsored by Johnson & Johnson Consumer Inc. (J&JCI) (formerly part of Johnson & Johnson) · Not applicable, Interventional, and Treatment
This study will test the safety and efficacy of three topical agents containing oat kernel flour to determine how well they relieve skin dryness and itching related to cancer therapies. Participants will receive a body wash, a body cream, and an anti-itch balm to use at home for 4-6 weeks.
Many patients undergoing cancer therapies experience skin reactions like dry skin, rash, redness, itchiness, and hyperpigmentation. Dry skin and itching are especially common for those undergoing chemotherapy and targeted treatments.
Skincare products containing Avena sativa (oat) kernel flour have a long history of tolerance and efficacy in treating various skin conditions involving pruritus (itching) and xerosis (dry skin), as Avena sativa (oat) kernel flour is known for its skin protectant properties and soothing effects on skin. This study will evaluate the safety and efficacy of a regimen of three topical agents containing Avena sativa (oat) kernel flour for cancer patients experiencing mild to moderate pruritus and/or xerosis.
Participants will received the products at Baseline (Visit 1) and return to the clinical site at Week 5 +/- 1 week for Visit 2. In addition, questionnaires will be completed remotely between Baseline and Visit 2.
33 studies on the registry are indexed under Ichthyosis; 11 are open to participants now.
This study's enrollment of 53 is above the median of 26 across 23 interventional studies indexed under Ichthyosis.
Browse Ichthyosis studies →Johnson & Johnson Consumer Inc. (J&JCI) is the lead sponsor of 55 studies on the registry; none are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 10 (83%) have results posted.
First submitted before Johnson & Johnson Consumer Inc. (J&JCI) left Johnson & Johnson.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
has a prior diagnosis of a solid or hematologic tumor and either:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Avena sativa-containing body wash, body cream, and anti-itch balm
Other: Avena Sativa Skincare Regimen
Regimen consisting of 3 topical agents containing Avena Sativa (oat) kernel flour: a body wash (type = cosmetic), a body cream (type = cosmetic), and an anti-itch balm (type = OTC monograph drug with 0.5% Pramoxine HCl)
Mean Change from Baseline to Visit 2 in CTCAE Grading of Xerosis
The investigator will evaluate subjects for overall xerosis (skin dryness) using the Common Terminology Criteria for Adverse Events (CTCAE) grading scale. For xerosis, the scale ranges from 1 (dryness covering less 10% of body surface area and no associated erythema or pruritus) to 3 (dryness covering greater than 30% of body surface area and associated with itching; limits daily self care activities of daily living). A "0" grade will be used to document subjects with no presence of the CTCAE skin adverse event symptoms for xerosis. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Time frame: Baseline to Week 5 +/- 1 week
Mean Change from Baseline to Visit 2 in CTCAE Grading of Pruritus
The investigator will evaluate subjects for overall pruritus (skin itching) using the Common Terminology Criteria for Adverse Events (CTCAE) grading scale. For pruritus, the scale ranges from 1 (Mild or localized; topical intervention indicated) to 3 (widespread and constant itching; limits daily self-care activities or sleep). A "0" grade will be used to document subjects with no presence of the CTCAE skin adverse event symptoms for pruritus. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Time frame: Baseline to Week 5 +/- 1 week
Mean Change from Baseline to Visit 2 in Overall Xerosis Grading
The investigator will evaluate subjects for overall xerosis (skin dryness) using a 0 (none) to 3 (severe) scale. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Time frame: Baseline to Week 5 +/- 1 week
Mean Change from Baseline to Visit 2 in Overall Pruritus Grading
The investigator will question subjects for overall pruritus (skin itching) using a 0 (none) to 3 (severe) scale. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Time frame: Baseline to Week 5 +/- 1 week
Mean Change from Baseline to Visit 2 in Overall Irritation Assessment
The investigator will evaluate subjects for overall irritation using a 0 (none) to 4 (very severe) scale. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Time frame: Baseline to Week 5 +/- 1 week
Frequency Distribution for Overall Tolerance at Visit 2 - Subject Rating
The subject will rate how well he/she tolerated the study regimen using the following choices: Well tolerated, tolerated, or not tolerated.
Time frame: Week 5 +/- 1 week
Frequency Distribution for Overall Tolerance at Visit 2 - Investigator Rating
The investigator will rate how well the participant tolerated the study regimen using the following choices: Well tolerated, tolerated, or not tolerated.
Time frame: Week 5 +/- 1 week
Mean Change from Baseline to Visit 2 in PRO-CTCAE Skin Dryness
The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) will be completed for Skin Dryness. The question asks subjects to rate the severity of their dry skin at its worst over the last 7 days from None to Very Severe on a 5-point scale. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Time frame: Baseline to Week 5 +/- 1 week
Mean Change from Baseline to Visit 2 in PRO-CTCAE Itching
The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) will be completed for Itching. The question asks subjects to rate the severity of their itchy skin at its worst over the last 7 days from None to Very Severe on a 5-point scale. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Time frame: Baseline to Week 5 +/- 1 week
Mean Change from Baseline to Visit 2 in Skindex-16 Global Score
The Skindex-16 is a dermatology-specific quality of life measuring tool. (The SKINDEX contact information and permission to use: Mapi Research Trust, Lyon, France. Internet: https://eprovide.mapi-trust.org). It contains 16 questions that ask subjects to rate how often over the last 7 days they have been bothered by various skin conditions on a scale of 0 (never bothered) to 6 (always bothered). The global score is the average score for all questions and is transformed to a linear scale ranging from 0 (never bothered) to 100 (always bothered) so a higher score indicates a lower quality of life. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Time frame: Baseline to Week 5 +/- 1 week
Mean Change from Baseline to Visit 2 in Skindex-16 Emotional Subscale
The Skindex-16 is a dermatology-specific quality of life measuring tool (The SKINDEX contact information and permission to use: Mapi Research Trust, Lyon, France. Internet: https://eprovide.mapi-trust.org). It contains 16 questions that ask subjects to rate how often over the last 7 days have they been bothered by various skin conditions on a scale of 0 (never bothered) to 6 (always bothered). The Emotional subscale looks at the average score of questions 5-11 regarding emotion; the emotional score is transformed to a linear scale ranging from 0 (never bothered) to 100 (always bothered) so a higher score indicates a lower quality of life. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Time frame: Baseline to Week 5 +/- 1 week
Mean Change from Baseline to Visit 2 in Skindex-16 Symptoms Subscale
The Skindex-16 is a dermatology-specific quality of life measuring tool (The SKINDEX contact information and permission to use: Mapi Research Trust, Lyon, France. Internet: https://eprovide.mapi-trust.org). It contains 16 questions that ask subjects to rate how often over the last 7 days have they been bothered by various skin conditions on a scale of 0 (never bothered) to 6 (always bothered). The Symptoms subscale looks at the average score of questions 1-4 individual responses regarding symptoms; the symptoms score is transformed to a linear scale ranging from 0 (never bothered) to 100 (always bothered) so a higher score indicates a lower quality of life. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Time frame: Baseline to Week 5 +/- 1 week
Mean Change from Baseline to Visit 2 in Skindex-16 Functional Subscale
The Skindex-16 is a dermatology-specific quality of life measuring tool (The SKINDEX contact information and permission to use: Mapi Research Trust, Lyon, France. Internet: https://eprovide.mapi-trust.org). It contains 16 questions that ask subjects to rate how often over the last 7 days have they been bothered by various skin conditions on a scale of 0 (never bothered) to 6 (always bothered). The Functional subscale looks at the average score of questions 12 - 16 regarding daily functioning; the functional score is transformed to a linear scale ranging from 0 (never bothered) to 100 (always bothered) so a higher score indicates a lower quality of life. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Time frame: Baseline to Week 5 +/- 1 week
Mean Change from Baseline to Visit 2 in Skin Moisture
Skin moisture will be measured with a Corneometer, with values ranging from 0 (no moisture) to 120 (most moisturized) arbitrary units. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Time frame: Baseline to Week 5 +/- 1 week
Mean Change from Baseline to Visit 2 in Skin Water Loss
The amount of water lost through the skin will be measured with a Vapometer. Higher numbers indicate more water loss. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Time frame: Baseline to Week 5 +/- 1 week
Mean Change from Baseline to Visit 2 in Self-Assessment of Dryness
Subjects will be asked to rate their overall skin dryness on a scale of 1 (very dry) to 10 (skin feels moisturized). Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Time frame: Baseline to Week 5 +/- 1 week
Mean Change from Baseline to Visit 2 in Self-Assessment of Flakiness
Subjects will be asked to rate their overall skin flakiness on a scale of 1 (flaking very apparent) to 10 (no visible flaking). Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Time frame: Baseline to Week 5 +/- 1 week
Mean Change from Baseline to Visit 2 in Self-Assessment of Itchiness
Subjects will be asked to rate their overall skin itchiness on a scale of 1 (very itchy) to 10 (not at all itchy). Baseline will be compared to the subjects' final visit (Week 5 +/- 1 weeks).
Time frame: Baseline to Week 5 +/- 1 week
Mean Change from Baseline to Visit 2 in Self-Assessment of Roughness
Subjects will be asked to rate their overall skin roughness/texture on a scale of 1 (very rough) to 10 (not at all rough). Baseline will be compared to the subjects' final visit (Week 5 +/- 1 weeks).
Time frame: Baseline to Week 5 +/- 1 week
Mean Change from Baseline to Visit 2 in Self-Assessment of Smoothness
Subjects will be asked to rate their overall skin smoothness on a scale of 1 (not at all smooth) to 10 (very smooth). Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Time frame: Baseline to Week 5 +/- 1 week
Mean Change from Baseline to Visit 2 in Self-Assessment of Softness
Subjects will be asked to rate their overall skin softness on a scale of 1 (not at all soft) to 10 (very soft). Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Time frame: Baseline to Week 5 +/- 1 week
Mean Change from Baseline to Visit 2 in Self-Assessment of Comfort
Subjects will be asked to rate their overall skin comfort on a scale of 1 (uncomfortable/irritated) to 10 (very comfortable/not at all irritated). Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Time frame: Baseline to Week 5 +/- 1 week
Mean Change from Baseline to Visit 2 in Self-Assessment of Overall Look/Feel
Subjects will be asked to rate the overall look and feel of their skin on a scale of 1 (not healthy looking) to 10 (healthy looking). Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Time frame: Baseline to Week 5 +/- 1 week
Plan to share: Yes — Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
Data sharing details ↗ · yoda.yale.edu.
Ran from May 2019 to primary completion in Dec 2019, 6 months.
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