Skin Toxicity in Patients on Checkpoint InhibitorsNCT07337486
"Evaluation of a Non-Pharmacological Skin Care Intervention for the Prevention and Treatment of Skin Toxicities Caused by Immunotherapy in Cancer Patients"
A study testing Shea Butter and Niacinamide and Argan Oil and Coconut Butter in people with Skin Toxicity in Patients on Checkpoint Inhibitors, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Due to recent approvals, a significant number of adult cancer patients are undergoing treatment with checkpoint inhibitor antibodies. While these treatments have revolutionized cancer care, they come with inherent risks of toxicities, primarily mediated by the patient's own immune system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Toxicity in Patients on Checkpoint Inhibitors
- What is being tested?
- Shea Butter and Niacinamide and Argan Oil and Coconut Butter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSpain
- Study dates
- 30 May 2022to 30 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient
- Diagnosed with any solid cancer
- Initiating treatment with checkpoint inhibitor antibodies
- Able to speak and understand Spanish and/or Catalan
Who cannot join
- Unable to sign informed consent
- Unable to comprehend the study for giving consent
- Language barrier: Does not speak or understand Spanish or Catalan
Trial locations and contacts
1 site in 1 country.
About this study
Due to recent approvals, a significant number of adult cancer patients are undergoing treatment with checkpoint inhibitor antibodies. While these treatments have revolutionized cancer care, they come with inherent risks of toxicities, primarily mediated by the patient's own immune system.
Among the most common side effects are dermatological toxicities, which although generally mild, significantly impact patients' quality of life. These issues are often underdiagnosed and lack proactive interventions. This study aims to demonstrate that proactive measures using Niacinamide and Shea Butter can either prevent or mitigate the severity of these toxicities.
Read more
Thus, this study seeks to contribute novel insights into managing patients undergoing active immunotherapy, a field that remains relatively unexplored. Dermocosmetic products used in both armes of this trial are already approved for over-the-counter use, ensuring accessibility without prescription.
Study Hypothesis: The prophylactic use of Niacinamide and Shea Butter in dermocosmetic products reduces the frequency and severity of immune-mediated skin toxicities in cancer patients receiving checkpoint inhibitor antibodies.
This single-center trial will be conducted at Hospital de la Santa Creu i Sant Pau, employing a parallel arm design with randomization overseen by the center's statistician. Participants will be randomly assigned to either arm, with an active control group to monitor dermocosmetic product usage frequency and type. The blinding protocol will be single-blind to ensure unbiased evaluation.
The study aims to assess the incidence of pruritus among adult cancer patients receiving checkpoint inhibitor antibodies, correlating these findings with the efficacy of dermocosmetic products containing Niacinamide and Shea Butter. Additionally, it will evaluate the impact on the quality of life of these patients.
The intervention group will receive soap and an emollient formulated with Shea Butter and Niacinamide, while the control group will use products containing Argan Oil and Coconut Butter. Both groups will undergo a 6-month treatment regimen.
Key endpoints include:
- Skin pruritus
- Relationship between skin condition and quality of life Consecutive non-probabilistic sampling will be used to recruit all patients with solid tumors initiating immunotherapy.
Using GranMo calculator version 7.2 with 95% confidence and a precision of +/- 0.07, the study calculated a sample size of 128 patients. Recruitment will aim for 130 patients to account for potential attrition, split evenly between Arm 1 and Arm 2.
Data analysis will involve importing, cleaning, and recoding variables followed by univariate analysis using IBM SPSS v.25 The study will adhere strictly to international ethical standards for clinical research, including the Declaration of Helsinki and Good Clinical Practice guidelines. Participants will be fully informed about the study's nature, objectives, procedures, potential risks, benefits, and their right to withdraw without impact on their care.
An information/consent form has been designed accordingly. Participants will receive hygiene and hydration products at no cost, though no financial compensation will be provided.
Monitoring, auditing, reviews by the CEIC, and regulatory inspections will be conducted to ensure adherence to protocol and regulatory requirements.
The choice of control treatment aims to replicate real-world conditions while assessing approved products. Participants will be followed for 6 months from informed consent signing.
- Being tested
- Shea Butter and Niacinamide, Argan Oil and Coconut Butter
- Keywords
- Immunotherapy, immune-mediated skin toxicity, Prevention, Checkpoint-inhibitors, Skin hygiene and hydration care, Cancer, Immuno-mediated cutaneous toxicity (pruritus and/or xerosis) in patients undergoing immunotherapy for cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shea Butter and NiacinamideOther
Thus, this study seeks to contribute novel insights into managing patients undergoing active immunotherapy, a field that remains relatively unexplored. Dermocosmetic products used in both armes of this trial are already approved for over-the-counter use, ensuring accessibility without prescription.
Argan Oil and Coconut ButterOther
Thus, this study seeks to contribute novel insights into managing patients undergoing active immunotherapy, a field that remains relatively unexplored. Dermocosmetic products used in both armes of this trial are already approved for over-the-counter use, ensuring accessibility without prescription.
| Study group | Role | What they receive |
|---|---|---|
| Niacinamide and Shea Butter | Experimental | Not described Receives: Other: Shea Butter and Niacinamide |
| Argan Oil and Coconut Butter | Active comparator | Not described Receives: Other: Argan Oil and Coconut Butter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective 1: Itching
Evaluate the occurrence of itching in adult cancer patients receiving treatment with Checkpoint Inhibitor Antibodies in relation to prevention with the use of dermocosmetic products based on Niacinamide and Shea Butter. The itch is measured using the itch intensity scale. It is a scale validated in both English and Spanish.
Measured: Baseline and 2, 4 and 6 months after starting immunotherapy
Objective 2: Skin quality of life
Evaluate the quality of life of adult cancer patients receiving treatment with Checkpoint Inhibitor Antibodies regarding skin health. The quality of life related to skin is evaluated using the Dermatology Life Quality Index (DLQI).
Measured: Baseline and 2, 4 and 6 months after starting immunotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start30 May 2022
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Skin Toxicity in Patients on Checkpoint InhibitorsStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337486
- Sponsor's protocol ID
- IIBSP-CUT-2021-109
- Status last verified
- Oct 2026
- First submitted
- 21 Jun 2024
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martins F, Sofiya L, Sykiotis GP, Lamine F, Maillard M, Fraga M, Shabafrouz K, Ribi C, Cairoli A, Guex-Crosier Y, Kuntzer T, Michielin O, Peters S, Coukos G, Spertini F, Thompson JA, Obeid M. Adverse effects of immune-checkpoint inhibitors: epidemiology, management and surveillance. Nat Rev Clin Oncol. 2019 Sep;16(9):563-580. doi: 10.1038/s41571-019-0218-0.
PubMed 31092901Davies M. How Checkpoint Inhibitors Are Changing the Treatment Paradigm in Solid Tumors: What Advanced Practitioners in Oncology Need to Know. J Adv Pract Oncol. 2016 Jul-Aug;7(5):498-509. Epub 2016 Jul 1.
PubMed 29282426Belum VR, Benhuri B, Postow MA, Hellmann MD, Lesokhin AM, Segal NH, Motzer RJ, Wu S, Busam KJ, Wolchok JD, Lacouture ME. Characterisation and management of dermatologic adverse events to agents targeting the PD-1 receptor. Eur J Cancer. 2016 Jun;60:12-25. doi: 10.1016/j.ejca.2016.02.010. Epub 2016 Apr 1.
PubMed 27043866Haanen JBAG, Carbonnel F, Robert C, Kerr KM, Peters S, Larkin J, Jordan K; ESMO Guidelines Committee. Management of toxicities from immunotherapy: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017 Jul 1;28(suppl_4):iv119-iv142. doi: 10.1093/annonc/mdx225. No abstract available.
PubMed 28881921Sibaud V. Dermatologic Reactions to Immune Checkpoint Inhibitors : Skin Toxicities and Immunotherapy. Am J Clin Dermatol. 2018 Jun;19(3):345-361. doi: 10.1007/s40257-017-0336-3.
PubMed 29256113Lacouture M, Sibaud V. Toxic Side Effects of Targeted Therapies and Immunotherapies Affecting the Skin, Oral Mucosa, Hair, and Nails. Am J Clin Dermatol. 2018 Nov;19(Suppl 1):31-39. doi: 10.1007/s40257-018-0384-3.
PubMed 30374901Macdonald JB, Macdonald B, Golitz LE, LoRusso P, Sekulic A. Cutaneous adverse effects of targeted therapies: Part I: Inhibitors of the cellular membrane. J Am Acad Dermatol. 2015 Feb;72(2):203-18; quiz 219-20. doi: 10.1016/j.jaad.2014.07.032.
PubMed 25592338Anforth R, Fernandez-Penas P, Long GV. Cutaneous toxicities of RAF inhibitors. Lancet Oncol. 2013 Jan;14(1):e11-8. doi: 10.1016/S1470-2045(12)70413-8.
PubMed 23276366
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Evaluation of a Non-Pharmacological Skin Care Intervention for the Prevention and Treatment of Skin Toxicities Caused by Immunotherapy in Cancer Patients"
- ClinicalTrials.gov ID
- NCT07337486
- Acronym / sponsor ID
- IIBSP-CUT-2021-109
- Keywords
- Immunotherapy, immune-mediated skin toxicity, Prevention, Checkpoint-inhibitors, Skin hygiene and hydration care, Cancer, Immuno-mediated cutaneous toxicity (pruritus and/or xerosis) in patients undergoing immunotherapy for cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Due to recent approvals, a significant number of adult cancer patients are undergoing treatment with checkpoint inhibitor antibodies. While these treatments have revolutionized cancer care, they come with inherent risks of toxicities, primarily mediated by the patient's own immune system.
Among the most common side effects are dermatological toxicities, which although generally mild, significantly impact patients' quality of life. These issues are often underdiagnosed and lack proactive interventions. This study aims to demonstrate that proactive measures using Niacinamide and Shea Butter can either prevent or mitigate the severity of these toxicities.
Thus, this study seeks to contribute novel insights into managing patients undergoing active immunotherapy, a field that remains relatively unexplored. Dermocosmetic products used in both armes of this trial are already approved for over-the-counter use, ensuring accessibility without prescription.
Study Hypothesis: The prophylactic use of Niacinamide and Shea Butter in dermocosmetic products reduces the frequency and severity of immune-mediated skin toxicities in cancer patients receiving checkpoint inhibitor antibodies.
This single-center trial will be conducted at Hospital de la Santa Creu i Sant Pau, employing a parallel arm design with randomization overseen by the center's statistician. Participants will be randomly assigned to either arm, with an active control group to monitor dermocosmetic product usage frequency and type. The blinding protocol will be single-blind to ensure unbiased evaluation.
The study aims to assess the incidence of pruritus among adult cancer patients receiving checkpoint inhibitor antibodies, correlating these findings with the efficacy of dermocosmetic products containing Niacinamide and Shea Butter. Additionally, it will evaluate the impact on the quality of life of these patients.
The intervention group will receive soap and an emollient formulated with Shea Butter and Niacinamide, while the control group will use products containing Argan Oil and Coconut Butter. Both groups will undergo a 6-month treatment regimen.
Key endpoints include:
- Skin pruritus
- Relationship between skin condition and quality of life Consecutive non-probabilistic sampling will be used to recruit all patients with solid tumors initiating immunotherapy.
Using GranMo calculator version 7.2 with 95% confidence and a precision of +/- 0.07, the study calculated a sample size of 128 patients. Recruitment will aim for 130 patients to account for potential attrition, split evenly between Arm 1 and Arm 2.
Data analysis will involve importing, cleaning, and recoding variables followed by univariate analysis using IBM SPSS v.25 The study will adhere strictly to international ethical standards for clinical research, including the Declaration of Helsinki and Good Clinical Practice guidelines. Participants will be fully informed about the study's nature, objectives, procedures, potential risks, benefits, and their right to withdraw without impact on their care.
An information/consent form has been designed accordingly. Participants will receive hygiene and hydration products at no cost, though no financial compensation will be provided.
Monitoring, auditing, reviews by the CEIC, and regulatory inspections will be conducted to ensure adherence to protocol and regulatory requirements.
The choice of control treatment aims to replicate real-world conditions while assessing approved products. Participants will be followed for 6 months from informed consent signing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Niacinamide and Shea Butter | Experimental | Other: Shea Butter and Niacinamide |
| Argan Oil and Coconut Butter | Active comparator | Other: Argan Oil and Coconut Butter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patient
- Diagnosed with any solid cancer
- Initiating treatment with checkpoint inhibitor antibodies
- Able to speak and understand Spanish and/or Catalan
Key exclusion criteria (3 listed)
- Unable to sign informed consent
- Unable to comprehend the study for giving consent
- Language barrier: Does not speak or understand Spanish or Catalan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shea Butter and NiacinamideThus, this study seeks to contribute novel insights into managing patients undergoing active immunotherapy, a field that remains relatively unexplored. Dermocosmetic products used in both armes of this trial are already approved for over-the-counter use, ensuring accessibility without prescription. | Other | Niacinamide and Shea Butter |
| Argan Oil and Coconut ButterThus, this study seeks to contribute novel insights into managing patients undergoing active immunotherapy, a field that remains relatively unexplored. Dermocosmetic products used in both armes of this trial are already approved for over-the-counter use, ensuring accessibility without prescription. | Other | Argan Oil and Coconut Butter |
Primary outcome
Objective 1: Itching
Time frame: Baseline and 2, 4 and 6 months after starting immunotherapy
Evaluate the occurrence of itching in adult cancer patients receiving treatment with Checkpoint Inhibitor Antibodies in relation to prevention with the use of dermocosmetic products based on Niacinamide and Shea Butter. The itch is measured using the itch intensity scale. It is a scale validated in both English and Spanish.
Objective 2: Skin quality of life
Time frame: Baseline and 2, 4 and 6 months after starting immunotherapy
Evaluate the quality of life of adult cancer patients receiving treatment with Checkpoint Inhibitor Antibodies regarding skin health. The quality of life related to skin is evaluated using the Dermatology Life Quality Index (DLQI).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Results publication: PubMed 31092901Martins F, Sofiya L, Sykiotis GP, Lamine F, Maillard M, Fraga M, Shabafrouz K, Ribi C, Cairoli A, Guex-Crosier Y, Kuntzer T, Michielin O, Peters S, Coukos G, Spertini F, Thompson JA, Obeid M. Adverse effects of immune-checkpoint inhibitors: epidemiology, management and surveillance. Nat Rev Clin Oncol. 2019 Sep;16(9):563-580. doi: 10.1038/s41571-019-0218-0.
- Results publication: PubMed 29282426Davies M. How Checkpoint Inhibitors Are Changing the Treatment Paradigm in Solid Tumors: What Advanced Practitioners in Oncology Need to Know. J Adv Pract Oncol. 2016 Jul-Aug;7(5):498-509. Epub 2016 Jul 1.
- Results publication: PubMed 27043866Belum VR, Benhuri B, Postow MA, Hellmann MD, Lesokhin AM, Segal NH, Motzer RJ, Wu S, Busam KJ, Wolchok JD, Lacouture ME. Characterisation and management of dermatologic adverse events to agents targeting the PD-1 receptor. Eur J Cancer. 2016 Jun;60:12-25. doi: 10.1016/j.ejca.2016.02.010. Epub 2016 Apr 1.
- Results publication: PubMed 28881921Haanen JBAG, Carbonnel F, Robert C, Kerr KM, Peters S, Larkin J, Jordan K; ESMO Guidelines Committee. Management of toxicities from immunotherapy: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017 Jul 1;28(suppl_4):iv119-iv142. doi: 10.1093/annonc/mdx225. No abstract available.
- Results publication: PubMed 29256113Sibaud V. Dermatologic Reactions to Immune Checkpoint Inhibitors : Skin Toxicities and Immunotherapy. Am J Clin Dermatol. 2018 Jun;19(3):345-361. doi: 10.1007/s40257-017-0336-3.
- Results publication: PubMed 30374901Lacouture M, Sibaud V. Toxic Side Effects of Targeted Therapies and Immunotherapies Affecting the Skin, Oral Mucosa, Hair, and Nails. Am J Clin Dermatol. 2018 Nov;19(Suppl 1):31-39. doi: 10.1007/s40257-018-0384-3.
- Results publication: PubMed 25592338Macdonald JB, Macdonald B, Golitz LE, LoRusso P, Sekulic A. Cutaneous adverse effects of targeted therapies: Part I: Inhibitors of the cellular membrane. J Am Acad Dermatol. 2015 Feb;72(2):203-18; quiz 219-20. doi: 10.1016/j.jaad.2014.07.032.
- Results publication: PubMed 23276366Anforth R, Fernandez-Penas P, Long GV. Cutaneous toxicities of RAF inhibitors. Lancet Oncol. 2013 Jan;14(1):e11-8. doi: 10.1016/S1470-2045(12)70413-8.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shea Butter and Niacinamide and Argan Oil and Coconut Butter in people with Skin Toxicity in Patients on Checkpoint Inhibitors, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective 1: Itching (time frame: Baseline and 2, 4 and 6 months after starting immunotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07337486, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.