A single-arm, observational study to explore and characterize wound healing after skin punch biopsies in healthy volunteers

Completed

• Conditions: 10014982; Wound healing

• Registration Number: NL-OMON44210
• Lead Sponsor: Centre for Human Drug Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

Eligible subjects must meet all of the following inclusion criteria at screening:
1. Healthy subjects, 18 to 30 years of age (inclusive). The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease following a detailed medical history, a complete physical examination including vital signs, blood sampling of hematology, chemistry, and virology, urinalysis, urine drug and cotinine testing, and alcohol breath testing. In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects.
2. Body mass index (BMI) between 18 and 30 kg/m2, inclusive
3. Fitzpatrick Skin type I-II (Caucasian type).
4. Eligible lower back to perform biopsies (no excessive hair growth, no local skin disorder)
5. Willing to give written informed consent and willing and able to comply with the study protocol.

Exclusion Criteria

Eligible subjects must meet none of the following exclusion criteria at screening:
1. History of pathological scar formation (keloid, hypertrophic scars)
2. Any form of body modification of the lower back hindering biopsy collection of unaltered skin (e.g. tattoos, piercings, implants)
3. Any disease associated with immune system impairment, including auto-immune diseases, HIV and transplantation patients.
4. Requirement of immunosuppressive or immunomodulatory medication, including glucocorticoids, non-steroid anti-inflammatory drugs (NSAIDs), and chemotherapeutic drugs within 30 days prior to enrollment or planned to use during the course of the study.
5. Have any current and / or recurrent pathologically, clinical significant relevant skin condition.
6. Use of topical medication (prescription or over-the-counter (OTC)) within 30 days of the start of the study in local treatment area.
7. Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding.
8. Current smoker and/or regular user of other nicotine-containing products (e.g., patches).
9. Average consumption of more than 14 units of alcohol per week
10. Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment or planned to do so during the course of the study
11. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.
12. Loss or donation of blood over 500 mL within three months prior to screening.
13. Any (medical) condition that would, in the opinion of the investigator, potentially compromise the safety or compliance of the subject or may preclude the subjects* successful completion of the clinical trial.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Endpoints<br /><br>* Biopsy biomarkers:<br /><br>o Histology with hematoxylin and eosin (HE) staining<br /><br>o Immunohistochemistry with wound healing related biomarkers (e.g. CD31,<br /><br>collagen I, collagen III, aSMA, fibronectin)<br /><br>o RNA sequencing (RNA-seq) or qRT-PCR for wound healing related biomarkers<br /><br>(e.g. VEGF*, TGF*1, TGF*2, TGF*3, PDGF, CTGF, TNF, IL-1B, IL-4, GM-CSF, IL-6,<br /><br>IL-10, MMP1, MMP3, OSM, LOX)<br /><br>* Local skin biomarkers for wound healing related biomarkers (e.g. VEGF-A,<br /><br>TNF*, IL-8, TLSP, MMP-3, IL-4) by transdermal analysis patch (TAP)<br /><br>* Clinical imaging (e.g. 2D and 3D photography, thermography, laser speckle<br /><br>contrast imaging (LSCI), trans epidermal water loss (TEWL), colorimetry)<br /><br>* Clinical evaluation (erythema grading scale, Red-Yellow-Black (RYB) wound<br /><br>assessment scale, the Patient and Observer Scar Assessment Scale (POSAS))<br /><br>* Skin microbiome (healthy and biopsy lesions)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Tolerability / safety endpoints<br /><br>* Adverse events (AEs)<br /><br>* Local tolerance (erythema grading scale, RYB wound assessment scale, NRS<br /><br>pruritus and pain, POSAS)</p><br>