Radiation-Induced Skin FibrosisPhase 1NCT07567235
Clinical Study of CFH Protein Via Ice Microneedles for Radiation-Induced Skin Fibrosis
A Phase 1 study testing CFH Protein-loaded Ice Microneedles (0.5 mg), CFH Protein-loaded Ice Microneedles (1.0 mg) and CFH Protein-loaded Ice Microneedles (2.0 mg) in people with Radiation-Induced Skin Fibrosis and Head and Neck Squamous Cell Carcinoma, run by West China Hospital at 1 site in China.
Trial summary
This phase I, open-label, single-arm, non-randomized clinical trial uses a "3+3" dose-escalation design to evaluate the safety, tolerability, and preliminary efficacy of intradermal delivery of complement factor H (CFH) fragment (human, 860-1231aa) via ice microneedles for the prevention of radiation-induced skin… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Radiation-Induced Skin Fibrosis, Head and Neck Squamous Cell Carcinoma
- What is being tested?
- CFH Protein-loaded Ice Microneedles (0.5 mg), CFH Protein-loaded Ice Microneedles (1.0 mg) and CFH Protein-loaded Ice Microneedles (2.0 mg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2026to 1 Mar 2027
- Phase
- Phase 1
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged 18 to 75 years (inclusive) at screening.
- Histologically confirmed head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma) scheduled to receive postoperative adjuvant radiotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Adequate major organ function within 7 days before treatment, meeting the following criteria:
- Hemoglobin ≥ 80 g/L; neutrophil count > 1.5 × 10⁹/L; platelet count ≥ 80 × 10⁹/L; Total bilirubin ≤ 1.5 × upper limit of normal (ULN); ALT or AST ≤ 2.5 × ULN (or ≤ 5 × ULN in the presence of liver metastases); Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 60 mL/min (Cockcroft-Gault formula); Prothrombin time (PT) and international normalized ratio (INR) ≤ 1.5 × ULN (unless on warfarin anticoagulation); Left ventricular ejection fraction (LVEF) ≥ 50%.
- Ability to understand and voluntarily sign a written informed consent form prior to any study procedures.
Who cannot join
- Presence of ulceration or open wound in the treatment area, or any contraindication to cutaneous administration including: Inflammation, trauma, or skin breakdown at the administration site; Severe bleeding or coagulation tendency (e.g., markedly low platelet or clotting factors); Any abnormality or permanent body art (e.g., tattoo) at the administration site that would interfere with observation of local reactions;
- Presence of connective tissue disease or other systemic dermatologic conditions (e.g., systemic lupus erythematosus, dermatomyositis, polymyositis, systemic sclerosis, scleroderma, toxic epidermal necrolysis, Stevens-Johnson syndrome, etc.).
- Known allergy to the investigational drug (including any excipients) or history of severe allergic reactions to any drug, food, or vaccine, such as anaphylactic shock, laryngeal edema, anaphylactic dyspnea, Henoch-Schönlein purpura, thrombocytopenic purpura, or Arthus reaction.
- Any uncontrolled clinical disease (e.g., respiratory, circulatory, digestive, nervous, hematologic, genitourinary, or endocrine system disease) or psychiatric disorder (e.g., depression, schizophrenia) that, in the investigator's judgment, would interfere with providing informed consent, interpretation of study results, pose additional risk to the patient, or otherwise compromise study objectives.
- Participation in another clinical trial of a drug or device within 3 months prior to screening.
- History of drug abuse or known medical, psychological, or social conditions (e.g., alcoholism or drug addiction).
- Pregnant or breastfeeding women, or women/partners planning pregnancy during the period from screening through 12 months after the last dose.
- Any other condition that, in the investigator's opinion, makes the patient unsuitable for participation in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610000
About this study
Official title: A Clinical Study to Evaluate the Safety and Tolerability of Intradermal Delivery of CFH Protein Via Ice Microneedles for the Prevention of Radiation-Induced Skin Fibrosis
This phase I, open-label, single-arm, non-randomized clinical trial uses a "3+3" dose-escalation design to evaluate the safety, tolerability, and preliminary efficacy of intradermal delivery of complement factor H (CFH) fragment (human, 860-1231aa) via ice microneedles for the prevention of radiation-induced skin fibrosis in patients with head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma) receiving postoperative adjuvant radiotherapy. The main questions are: 1. The safety profile, including dose-limiting toxicities (DLTs) within 28 days after the first dose, adverse events, and tolerability. 2.Preliminary efficacy, assessed by changes in irradiated skin thickness, palpation of fibrotic area, CTCAE grade ≤2 fibrosis rate, and quality of life. Participants receive CFH ice microneedle patches twice weekly for a total of 8 doses (starting at 0.5 mg, escalating to 1.0 mg and 2.0 mg), applied to the skin area to be irradiated.
- Being tested
- CFH Protein-loaded Ice Microneedles (0.5 mg), CFH Protein-loaded Ice Microneedles (1.0 mg), CFH Protein-loaded Ice Microneedles (2.0 mg)
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CFH Protein-loaded Ice Microneedles (0.5 mg)Biological
Recombinant human CFH protein delivered intradermally via ice microneedle patches at a total dose of 0.5 mg per administration, twice weekly for a total of 8 doses, starting on the first day of radiotherapy.
CFH Protein-loaded Ice Microneedles (1.0 mg)Biological
Recombinant human CFH protein delivered intradermally via ice microneedle patches at a total dose of 1.0 mg per administration, twice weekly for a total of 8 doses, starting on the first day of radiotherapy.
CFH Protein-loaded Ice Microneedles (2.0 mg)Biological
Recombinant human CFH protein delivered intradermally via ice microneedle patches at a total dose of 2.0 mg per administration, twice weekly for a total of 8 doses, starting on the first day of radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1: CFH Protein 0.5 mg via Ice Microneedles | Experimental | Participants receive intradermal delivery of CFH protein at a total dose of 0.5 mg per administration via ice microneedle patches, twice weekly for a total of 8 doses, starting on the first day of radiotherapy. Receives: Biological: CFH Protein-loaded Ice Microneedles (0.5 mg) |
| Dose Level 2: CFH Protein 1.0 mg via Ice Microneedles | Experimental | Participants receive intradermal delivery of CFH protein at a total dose of 1.0 mg per administration via ice microneedle patches, twice weekly for a total of 8 doses, starting on the first day of radiotherapy. Receives: Biological: CFH Protein-loaded Ice Microneedles (1.0 mg) |
| Dose Level 3: CFH Protein 2.0 mg via Ice Microneedles | Experimental | Participants receive intradermal delivery of CFH protein at a total dose of 2.0 mg per administration via ice microneedle patches, twice weekly for a total of 8 doses, starting on the first day of radiotherapy. Receives: Biological: CFH Protein-loaded Ice Microneedles (2.0 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities (DLTs)
Number of participants experiencing DLT within 28 days after the first dose of CFH protein delivered via ice microneedles.
Measured: First 28 days after the first study drug administration
Incidence and Severity of Adverse Events (AEs)
Number of participants with adverse events, graded according to NCI CTCAE v5.0.
Measured: Total study period up to approximately 6 months post-radiotherapy
Secondary outcomes (7)
Change in Irradiated Skin Thickness
Change in skin thickness of the irradiated area measured by ultrasound.
Measured: Baseline (pre-radiotherapy) to within 6 months after completion of radiotherapy
Change in Palpable Fibrotic Area (Surface Area and Volume)
Change in surface area (length × width) and volume (surface area × thickness) of palpable skin fibrosis in the irradiated area.
Measured: Baseline (pre-radiotherapy) to within 6 months after completion of radiotherapy
Number of Participants with CTCAE Grade ≤2 Fibrosis
Number of participants who develop radiation-induced skin fibrosis of grade ≤2 according to NCI CTCAE v5.0.
Measured: Within 6 months after completion of radiotherapy
Change in Skindex Life Quality Index (SQLI) score-16
Change in QoL scores assessed by SQLI-16 questionnaires. Minimum Value：0 Maximum Value：100 Higher Score Means：Worse outcome (higher score indicates greater impairment of quality of life)
Measured: Baseline (pre-radiotherapy) to within 6 months after completion of radiotherapy
Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) score
Change in QoL scores assessed by QLQ-C30 questionnaires. Minimum Value：0 Maximum Value：100 Higher Score Means：For Global Health Status / QoL scale：Better outcome
Measured: Baseline (pre-radiotherapy) to within 6 months after completion of radiotherapy
Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Cancer Module (EORTC QLQ-H&N35) score
Change in QoL scores assessed by QLQ-H\&N35 questionnaires. Minimum Value：0 Maximum Value：100 Higher Score Means：Worse outcome (higher score indicates more severe symptoms/problems)
Measured: Baseline (pre-radiotherapy) to within 6 months after completion of radiotherapy
Change in Dermatology Life Quality Index (DLQI) score
Change in QoL scores assessed by DLQl questionnaires. Minimum Value：0 Maximum Value：30 Higher Score Means：Worse outcome (higher score indicates greater impairment of skin-related quality of life)
Measured: Baseline (pre-radiotherapy) to within 6 months after completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start15 Jun 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Radiation-Induced Skin FibrosisStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingchen Peng, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07567235
- Sponsor's protocol ID
- HX 2026-339
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jozsi M, Schneider AE, Karpati E, Sandor N. Complement factor H family proteins in their non-canonical role as modulators of cellular functions. Semin Cell Dev Biol. 2019 Jan;85:122-131. doi: 10.1016/j.semcdb.2017.12.018. Epub 2018 Jan 5.
PubMed 29305301Delanian S, Porcher R, Rudant J, Lefaix JL. Kinetics of response to long-term treatment combining pentoxifylline and tocopherol in patients with superficial radiation-induced fibrosis. J Clin Oncol. 2005 Dec 1;23(34):8570-9. doi: 10.1200/JCO.2005.02.4729. Epub 2005 Oct 31.
PubMed 16260695Gothard L, Cornes P, Earl J, Hall E, MacLaren J, Mortimer P, Peacock J, Peckitt C, Woods M, Yarnold J. Double-blind placebo-controlled randomised trial of vitamin E and pentoxifylline in patients with chronic arm lymphoedema and fibrosis after surgery and radiotherapy for breast cancer. Radiother Oncol. 2004 Nov;73(2):133-9. doi: 10.1016/j.radonc.2004.09.013.
PubMed 15542159Fijardo M, Kwan JYY, Bissey PA, Citrin DE, Yip KW, Liu FF. The clinical manifestations and molecular pathogenesis of radiation fibrosis. EBioMedicine. 2024 May;103:105089. doi: 10.1016/j.ebiom.2024.105089. Epub 2024 Apr 5.
PubMed 38579363Straub JM, New J, Hamilton CD, Lominska C, Shnayder Y, Thomas SM. Radiation-induced fibrosis: mechanisms and implications for therapy. J Cancer Res Clin Oncol. 2015 Nov;141(11):1985-94. doi: 10.1007/s00432-015-1974-6. Epub 2015 Apr 25.
PubMed 25910988Mayor S. WHO priority list of medical devices for cancer management. Lancet Oncol. 2017 Jul;18(7):856. doi: 10.1016/S1470-2045(17)30407-2. Epub 2017 May 25. No abstract available.
PubMed 28552214
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Safety and Tolerability of Intradermal Delivery of CFH Protein Via Ice Microneedles for the Prevention of Radiation-Induced Skin Fibrosis
- ClinicalTrials.gov ID
- NCT07567235
- Acronym / sponsor ID
- HX 2026-339
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 5 May 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.
This phase I, open-label, single-arm, non-randomized clinical trial uses a "3+3" dose-escalation design to evaluate the safety, tolerability, and preliminary efficacy of intradermal delivery of complement factor H (CFH) fragment (human, 860-1231aa) via ice microneedles for the prevention of radiation-induced skin fibrosis in patients with head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma) receiving postoperative adjuvant radiotherapy. The main questions are: 1. The safety profile, including dose-limiting toxicities (DLTs) within 28 days after the first dose, adverse events, and tolerability. 2.Preliminary efficacy, assessed by changes in irradiated skin thickness, palpation of fibrotic area, CTCAE grade ≤2 fibrosis rate, and quality of life. Participants receive CFH ice microneedle patches twice weekly for a total of 8 doses (starting at 0.5 mg, escalating to 1.0 mg and 2.0 mg), applied to the skin area to be irradiated.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1: CFH Protein 0.5 mg via Ice Microneedles | Experimental | Biological: CFH Protein-loaded Ice Microneedles (0.5 mg)Participants receive intradermal delivery of CFH protein at a total dose of 0.5 mg per administration via ice microneedle patches, twice weekly for a total of 8 doses, starting on the first day of radiotherapy. |
| Dose Level 2: CFH Protein 1.0 mg via Ice Microneedles | Experimental | Biological: CFH Protein-loaded Ice Microneedles (1.0 mg)Participants receive intradermal delivery of CFH protein at a total dose of 1.0 mg per administration via ice microneedle patches, twice weekly for a total of 8 doses, starting on the first day of radiotherapy. |
| Dose Level 3: CFH Protein 2.0 mg via Ice Microneedles | Experimental | Biological: CFH Protein-loaded Ice Microneedles (2.0 mg)Participants receive intradermal delivery of CFH protein at a total dose of 2.0 mg per administration via ice microneedle patches, twice weekly for a total of 8 doses, starting on the first day of radiotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients aged 18 to 75 years (inclusive) at screening.
- Histologically confirmed head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma) scheduled to receive postoperative adjuvant radiotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Adequate major organ function within 7 days before treatment, meeting the following criteria:
- Hemoglobin ≥ 80 g/L; neutrophil count > 1.5 × 10⁹/L; platelet count ≥ 80 × 10⁹/L; Total bilirubin ≤ 1.5 × upper limit of normal (ULN); ALT or AST ≤ 2.5 × ULN (or ≤ 5 × ULN in the presence of liver metastases); Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 60 mL/min (Cockcroft-Gault formula); Prothrombin time (PT) and international normalized ratio (INR) ≤ 1.5 × ULN (unless on warfarin anticoagulation); Left ventricular ejection fraction (LVEF) ≥ 50%.
Key exclusion criteria (8 listed)
- Presence of ulceration or open wound in the treatment area, or any contraindication to cutaneous administration including: Inflammation, trauma, or skin breakdown at the administration site; Severe bleeding or coagulation tendency (e.g., markedly low platelet or clotting factors); Any abnormality or permanent body art (e.g., tattoo) at the administration site that would interfere with observation of local reactions;
- Presence of connective tissue disease or other systemic dermatologic conditions (e.g., systemic lupus erythematosus, dermatomyositis, polymyositis, systemic sclerosis, scleroderma, toxic epidermal necrolysis, Stevens-Johnson syndrome, etc.).
- Known allergy to the investigational drug (including any excipients) or history of severe allergic reactions to any drug, food, or vaccine, such as anaphylactic shock, laryngeal edema, anaphylactic dyspnea, Henoch-Schönlein purpura, thrombocytopenic purpura, or Arthus reaction.
- Any uncontrolled clinical disease (e.g., respiratory, circulatory, digestive, nervous, hematologic, genitourinary, or endocrine system disease) or psychiatric disorder (e.g., depression, schizophrenia) that, in the investigator's judgment, would interfere with providing informed consent, interpretation of study results, pose additional risk to the patient, or otherwise compromise study objectives.
- Participation in another clinical trial of a drug or device within 3 months prior to screening.
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 |
|---|---|---|
| CFH Protein-loaded Ice Microneedles (0.5 mg)Recombinant human CFH protein delivered intradermally via ice microneedle patches at a total dose of 0.5 mg per administration, twice weekly for a total of 8 doses, starting on the first day of radiotherapy. | Biological | Dose Level 1: CFH Protein 0.5 mg via Ice Microneedles |
| CFH Protein-loaded Ice Microneedles (1.0 mg)Recombinant human CFH protein delivered intradermally via ice microneedle patches at a total dose of 1.0 mg per administration, twice weekly for a total of 8 doses, starting on the first day of radiotherapy. | Biological | Dose Level 2: CFH Protein 1.0 mg via Ice Microneedles |
| CFH Protein-loaded Ice Microneedles (2.0 mg)Recombinant human CFH protein delivered intradermally via ice microneedle patches at a total dose of 2.0 mg per administration, twice weekly for a total of 8 doses, starting on the first day of radiotherapy. | Biological | Dose Level 3: CFH Protein 2.0 mg via Ice Microneedles |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: First 28 days after the first study drug administration
Number of participants experiencing DLT within 28 days after the first dose of CFH protein delivered via ice microneedles.
Incidence and Severity of Adverse Events (AEs)
Time frame: Total study period up to approximately 6 months post-radiotherapy
Number of participants with adverse events, graded according to NCI CTCAE v5.0.
7 secondary outcomes
Change in Irradiated Skin Thickness
Time frame: Baseline (pre-radiotherapy) to within 6 months after completion of radiotherapy
Change in Palpable Fibrotic Area (Surface Area and Volume)
Time frame: Baseline (pre-radiotherapy) to within 6 months after completion of radiotherapy
Number of Participants with CTCAE Grade ≤2 Fibrosis
Time frame: Within 6 months after completion of radiotherapy
Change in Skindex Life Quality Index (SQLI) score-16
Time frame: Baseline (pre-radiotherapy) to within 6 months after completion of radiotherapy
Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) score
Time frame: Baseline (pre-radiotherapy) to within 6 months after completion of radiotherapy
Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Cancer Module (EORTC QLQ-H&N35) score
Time frame: Baseline (pre-radiotherapy) to within 6 months after completion of radiotherapy
Change in Dermatology Life Quality Index (DLQI) score
Time frame: Baseline (pre-radiotherapy) to within 6 months after completion of radiotherapy
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 8 Jul 2026.
- Background: PubMed 29305301Jozsi M, Schneider AE, Karpati E, Sandor N. Complement factor H family proteins in their non-canonical role as modulators of cellular functions. Semin Cell Dev Biol. 2019 Jan;85:122-131. doi: 10.1016/j.semcdb.2017.12.018. Epub 2018 Jan 5.
- Background: PubMed 16260695Delanian S, Porcher R, Rudant J, Lefaix JL. Kinetics of response to long-term treatment combining pentoxifylline and tocopherol in patients with superficial radiation-induced fibrosis. J Clin Oncol. 2005 Dec 1;23(34):8570-9. doi: 10.1200/JCO.2005.02.4729. Epub 2005 Oct 31.
- Background: PubMed 15542159Gothard L, Cornes P, Earl J, Hall E, MacLaren J, Mortimer P, Peacock J, Peckitt C, Woods M, Yarnold J. Double-blind placebo-controlled randomised trial of vitamin E and pentoxifylline in patients with chronic arm lymphoedema and fibrosis after surgery and radiotherapy for breast cancer. Radiother Oncol. 2004 Nov;73(2):133-9. doi: 10.1016/j.radonc.2004.09.013.
- Background: PubMed 38579363Fijardo M, Kwan JYY, Bissey PA, Citrin DE, Yip KW, Liu FF. The clinical manifestations and molecular pathogenesis of radiation fibrosis. EBioMedicine. 2024 May;103:105089. doi: 10.1016/j.ebiom.2024.105089. Epub 2024 Apr 5.
- Background: PubMed 25910988Straub JM, New J, Hamilton CD, Lominska C, Shnayder Y, Thomas SM. Radiation-induced fibrosis: mechanisms and implications for therapy. J Cancer Res Clin Oncol. 2015 Nov;141(11):1985-94. doi: 10.1007/s00432-015-1974-6. Epub 2015 Apr 25.
- Background: PubMed 28552214Mayor S. WHO priority list of medical devices for cancer management. Lancet Oncol. 2017 Jul;18(7):856. doi: 10.1016/S1470-2045(17)30407-2. Epub 2017 May 25. No abstract available.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CFH Protein-loaded Ice Microneedles (0.5 mg), CFH Protein-loaded Ice Microneedles (1.0 mg) and CFH Protein-loaded Ice Microneedles (2.0 mg) in people with Radiation-Induced Skin Fibrosis and Head and Neck Squamous Cell Carcinoma, run by West China Hospital at 1 site in China.
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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 8 Jul 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 China. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Xingchen Peng, MD, PhD (+8618980606753, pxx2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicities (DLTs) (time frame: First 28 days after the first study drug administration). 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 NCT07567235, which also lists 6 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 8 Jul 2026.