RejuvenationNCT07306130
Consensus on Skin Care in Breast Cancer Patients
An observational study of Rejuvenation and Skin Care Dermocosmetics, run by Venus Research Center at 1 site in Egypt.
Trial summary
Skin toxicity is one of the most common and impactful adverse effects of breast cancer treatment, affecting patients undergoing chemotherapy, targeted therapies, endocrine therapy, and radiotherapy. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rejuvenation, Skin Care Dermocosmetics, Breast Cancer
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2025to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A purposively selected group of dermatology and aesthetic medicine experts from Egypt and the broader MENA region. Participants are clinicians with significant experience in skin care in breast cancer patients and are invited to contribute to a structured Modified Delphi process to develop regional consensus recommendations.
Who may be able to join
- Clinical Expertise: Must be a practicing healthcare professional (HCP) with a minimum of [e.g., 5-10] years of clinical experience in breast cancer management, supportive care, or oncology-related dermatology.
- Geographic and Practice Diversity: Representation from different geographical regions and practice settings (e.g., academic centers, community hospitals) to ensure broad applicability of the recommendations.
- Availability and Willingness to Participate: Must formally agree to commit to the entire multi-round Delphi process (typically 2-4 rounds) within the specified timeline.
Who cannot join
- Inability or unwillingness to complete Delphi rounds.
- Lack of clinical experience with breast cancer patients.
- Industry representatives without direct clinical practice.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Skin toxicity is one of the most common and impactful adverse effects of breast cancer treatment, affecting patients undergoing chemotherapy, targeted therapies, endocrine therapy, and radiotherapy. Current research and expert consensus highlight the importance of early, preventive, and gentle skin-care regimens to preserve barrier function and reduce treatment interruptions. Evidence supports the use of mild, fragrance-free cleansers, twice-daily emollient moisturization, and consistent broad-spectrum photoprotection throughout therapy. For radiation dermatitis, studies show that prophylactic moisturizers, silicone- or hydrofilm-based dressings, and short-course topical corticosteroids significantly reduce severity. Targeted therapies, particularly EGFR/HER2 inhibitors, require anticipatory management with barrier repair, topical anti-inflammatory agents, and oral antibiotics when papulopustular eruptions develop. Dermocosmetic products designed for sensitive or oncology-treated skin have demonstrated improvements in symptom burden and quality of life. Overall, the consensus emphasizes patient education, avoidance of irritants, multidisciplinary dermatologic-oncologic collaboration, and proactive rather than reactive care to effectively mitigate skin-related adverse events in breast cancer patients.
Read the detailed description
Study Overview
This study is a non-interventional, observational expert consensus project designed to develop region-appropriate guidelines for skin care management in breast cancer patients undergoing systemic therapies, radiotherapy, or surgical treatment. Although numerous international guidelines address cancer-related skin toxicities, most are derived from Western populations and do not fully reflect regional differences in skin phototypes (Fitzpatrick III-VI), environmental factors, product availability, and care pathways common in the Middle East and North Africa (MENA) region. Because breast cancer patients frequently experience treatment-related dermatologic adverse events that affect quality of life and treatment adherence, a structured expert consensus is required to standardize preventive and therapeutic skin-care practices across oncology and dermatology settings.
Study Design
This study follows a Modified Delphi methodology, The Delphi process will include 2-3 iterative rounds:
Round 1 - Qualitative Item Generation
Experts will complete an open-ended questionnaire covering:
baseline skin-care recommendations (cleansing, moisturization, photoprotection); management of radiotherapy-induced dermatitis; chemotherapy- and targeted-therapy-related skin toxicities (xerosis, papulopustular rash, nail changes, photosensitivity); surgical wound and scar care; use of dermocosmetics and supportive products during cancer therapy; safety considerations for Fitzpatrick III-VI skin; contraindicated products or procedures (exfoliants, retinoids, lasers, waxing);
patient-education strategies; follow-up schedules and referral pathways; regional barriers (product availability, cultural factors, climate impact). Responses will undergo thematic analysis to produce structured statements.
Round 2 - Quantitative Consensus Rating
Panelists will rate the consolidated statements using a 9-point Likert scale (1 = inappropriate, 9 = appropriate), assessing clinical utility, safety, feasibility, and applicability to breast cancer care in the MENA region.
Optional Round 3
Only statements without clear consensus will undergo a third round. Experts will review anonymized group statistics (median, distribution spread) and re-rate remaining borderline items, allowing refinement of near-agreement topics.
Expert Panel Selection
Experts will be eligible if they meet at least two of the following criteria:
- ≥5 years of clinical experience in dermatology, oncology, or supportive cancer care;
- Recognized national or regional lecturer, trainer, or key opinion leader;
- Peer-reviewed publications in dermatology, oncology, supportive care, or cancer survivorship;
- Active practice within Egypt or other MENA countries.
The targeted panel size is 15-25 experts, ensuring representation across dermatology, radiation oncology, medical oncology, nursing, and survivorship care.
Statistical Analysis For each item, the following will be calculated: median, interquartile range, interpercentile range (IPR), IPR adjusted for symmetry (IPRAS), and the Disagreement Index. Items will be categorized by agreement level and summarized for publication. Subgroup analyses (e.g., GCC vs North Africa) may be performed.
Ethical Considerations This study does not involve patients, clinical interventions, or personal health information. Participation is voluntary. Expert responses are anonymized. No foreseeable risks are associated with participation, and the study qualifies as minimal-risk, non-interventional research.
- Conditions
- Rejuvenation, Skin Care Dermocosmetics, Breast Cancer
- Keywords
- Dermocosmetics, skin care, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Oncodermatology-Focused Skincare | A cohort of dermatology and aesthetic medicine experts from the MENA region participating in a Modified Delphi process to develop consensus recommendations on Skin care in Breast Cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of Consensus on Skin Care in Breast Cancer patients
The final set of evidence-based and/or expert-supported statements, interventions, or practice recommendations for skin care in breast cancer patients that reach a pre-defined threshold of agreement among the expert panel.
Measured: 6-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start1 Nov 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RejuvenationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Venus Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306130
- Sponsor's protocol ID
- Breast Cancer-Venus
- Status last verified
- Nov 2025
- First submitted
- 6 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Delphi studies do not collect patient data, medical records, biological samples, or identifiable clinical information. Experts only give opinions, not "IPD." Their responses are anonymized, and sharing identifiable expert-level responses is not required and often discouraged
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consensus on Skin Care in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT07306130
- Acronym / sponsor ID
- Breast Cancer-Venus
- Conditions
- Rejuvenation, Skin Care Dermocosmetics, Breast Cancer
- Keywords
- Dermocosmetics, skin care, Breast Cancer
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Venus Research CenterUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 29 Dec 2025 (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.
Skin toxicity is one of the most common and impactful adverse effects of breast cancer treatment, affecting patients undergoing chemotherapy, targeted therapies, endocrine therapy, and radiotherapy. Current research and expert consensus highlight the importance of early, preventive, and gentle skin-care regimens to preserve barrier function and reduce treatment interruptions. Evidence supports the use of mild, fragrance-free cleansers, twice-daily emollient moisturization, and consistent broad-spectrum photoprotection throughout therapy. For radiation dermatitis, studies show that prophylactic moisturizers, silicone- or hydrofilm-based dressings, and short-course topical corticosteroids significantly reduce severity. Targeted therapies, particularly EGFR/HER2 inhibitors, require anticipatory management with barrier repair, topical anti-inflammatory agents, and oral antibiotics when papulopustular eruptions develop. Dermocosmetic products designed for sensitive or oncology-treated skin have demonstrated improvements in symptom burden and quality of life. Overall, the consensus emphasizes patient education, avoidance of irritants, multidisciplinary dermatologic-oncologic collaboration, and proactive rather than reactive care to effectively mitigate skin-related adverse events in breast cancer patients.
Detailed description
Study Overview
This study is a non-interventional, observational expert consensus project designed to develop region-appropriate guidelines for skin care management in breast cancer patients undergoing systemic therapies, radiotherapy, or surgical treatment. Although numerous international guidelines address cancer-related skin toxicities, most are derived from Western populations and do not fully reflect regional differences in skin phototypes (Fitzpatrick III-VI), environmental factors, product availability, and care pathways common in the Middle East and North Africa (MENA) region. Because breast cancer patients frequently experience treatment-related dermatologic adverse events that affect quality of life and treatment adherence, a structured expert consensus is required to standardize preventive and therapeutic skin-care practices across oncology and dermatology settings.
Study Design
This study follows a Modified Delphi methodology, The Delphi process will include 2-3 iterative rounds:
Round 1 - Qualitative Item Generation
Experts will complete an open-ended questionnaire covering:
baseline skin-care recommendations (cleansing, moisturization, photoprotection); management of radiotherapy-induced dermatitis; chemotherapy- and targeted-therapy-related skin toxicities (xerosis, papulopustular rash, nail changes, photosensitivity); surgical wound and scar care; use of dermocosmetics and supportive products during cancer therapy; safety considerations for Fitzpatrick III-VI skin; contraindicated products or procedures (exfoliants, retinoids, lasers, waxing);
patient-education strategies; follow-up schedules and referral pathways; regional barriers (product availability, cultural factors, climate impact). Responses will undergo thematic analysis to produce structured statements.
Round 2 - Quantitative Consensus Rating
Panelists will rate the consolidated statements using a 9-point Likert scale (1 = inappropriate, 9 = appropriate), assessing clinical utility, safety, feasibility, and applicability to breast cancer care in the MENA region.
Optional Round 3
Only statements without clear consensus will undergo a third round. Experts will review anonymized group statistics (median, distribution spread) and re-rate remaining borderline items, allowing refinement of near-agreement topics.
Expert Panel Selection
Experts will be eligible if they meet at least two of the following criteria:
- ≥5 years of clinical experience in dermatology, oncology, or supportive cancer care;
- Recognized national or regional lecturer, trainer, or key opinion leader;
- Peer-reviewed publications in dermatology, oncology, supportive care, or cancer survivorship;
- Active practice within Egypt or other MENA countries.
The targeted panel size is 15-25 experts, ensuring representation across dermatology, radiation oncology, medical oncology, nursing, and survivorship care.
Statistical Analysis For each item, the following will be calculated: median, interquartile range, interpercentile range (IPR), IPR adjusted for symmetry (IPRAS), and the Disagreement Index. Items will be categorized by agreement level and summarized for publication. Subgroup analyses (e.g., GCC vs North Africa) may be performed.
Ethical Considerations This study does not involve patients, clinical interventions, or personal health information. Participation is voluntary. Expert responses are anonymized. No foreseeable risks are associated with participation, and the study qualifies as minimal-risk, non-interventional research.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oncodermatology-Focused Skincare | – | –A cohort of dermatology and aesthetic medicine experts from the MENA region participating in a Modified Delphi process to develop consensus recommendations on Skin care in Breast Cancer. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A purposively selected group of dermatology and aesthetic medicine experts from Egypt and the broader MENA region. Participants are clinicians with significant experience in skin care in breast cancer patients and are invited to contribute to a structured Modified Delphi process to develop regional consensus recommendations.
Key inclusion criteria (3 listed)
- Clinical Expertise: Must be a practicing healthcare professional (HCP) with a minimum of [e.g., 5-10] years of clinical experience in breast cancer management, supportive care, or oncology-related dermatology.
- Geographic and Practice Diversity: Representation from different geographical regions and practice settings (e.g., academic centers, community hospitals) to ensure broad applicability of the recommendations.
- Availability and Willingness to Participate: Must formally agree to commit to the entire multi-round Delphi process (typically 2-4 rounds) within the specified timeline.
Key exclusion criteria (3 listed)
- Inability or unwillingness to complete Delphi rounds.
- Lack of clinical experience with breast cancer patients.
- Industry representatives without direct clinical practice.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Achievement of Consensus on Skin Care in Breast Cancer patients
Time frame: 6-12 weeks
The final set of evidence-based and/or expert-supported statements, interventions, or practice recommendations for skin care in breast cancer patients that reach a pre-defined threshold of agreement among the expert panel.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: No. Delphi studies do not collect patient data, medical records, biological samples, or identifiable clinical information. Experts only give opinions, not "IPD." Their responses are anonymized, and sharing identifiable expert-level responses is not required and often discouraged
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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.
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?
An observational study of Rejuvenation and Skin Care Dermocosmetics, run by Venus Research Center at 1 site in Egypt.
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 3 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: enrolling by invitation, as of the sponsor's last update on 29 Dec 2025. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
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?
Achievement of Consensus on Skin Care in Breast Cancer patients (time frame: 6-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2025.