A SINGLE CENTER, OPEN-LABEL, CLINICAL STUDY TOEVALUATE THE ABILITY OF DERMAL OPEN FLOW MICROPERFUSION (DOFM) FORBIOEQUIVALENCE TESTING OF TOPICALLY APPLIED DICLOFENAC SODIUM PRODUCTSIN HEALTHY SUBJECTS

Phase 1

• Conditions: Healthy Subjects

• Registration Number: DRKS00023279
• Lead Sponsor: HEALTH – Institute for Biomedicine and Health Sciences, JOANNEUM RESEARCH Ges.mbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-15
• Study Completion: 2021-08-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Subject candidates must fulfill all of the following inclusion criteria to be eligible for participation in the study:
1. Healthy, adult volunteers of age 18 to 65 years (both inclusive).
2. Males or non-pregnant, non-breast feeding females using adequate contraceptive methods or abstinence.
3. Able to read, understand and sign the written informed consent form.
4. Willing to follow the protocol requirements and comply with protocol restrictions.

Exclusion Criteria

Subjects must not be enrolled in the study if they meet any of the following criteria:
1. Social habits
a. Smoker who is not willing to refrain from smoking during the in-house visit.
b. History of drug and/or alcohol abuse within one year of start of study as judged by the investigator.
2. Medications: Use of any medications other than hormonal contraceptive, hormone replacement therapy or routine vitamins within the 7 days or 5 half-life periods whichever is longer prior to the initial dose of study medication.
3. Diseases: Presence of any clinically relevant acute or chronic disease, which in the investigator´s opinion might jeopardise subject`s safety, evaluation of results or compliance with the protocol.
4. Any reason, which in the opinion of the investigator, would prevent the subject from safely participating in the study.
5. Any abnormalities found during physical examination or vital signs, unless deemed not clinically significant by the investigator.
6. Clinically significant abnormal laboratory evaluation results, as deemed by the investigator.
7. Clinically significant abnormal 12-lead ECG at screening, as deemed by the investigator.
8. Positive results to the test for hepatitis B antigen or hepatitis C antibodies.
9. Positive HIV test.
10. Positive alcohol breath test.
11. Blood donation within 30 days or significant loss of blood or plasma (more than 550 ml) within 90 days prior to screening.
12. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
13. Known hypersensitivity to diclofenac or any components of the drugsa.
14. Tattoos or broken and/or damaged skin and/or scarring at the application areas.
15. Active skin diseases like psoriasis or atopic dermatitis, as judged by the investigator.
16. Subjects prone to keloid or hypertrophic scar formation or any known wound healing disorder.
17. Recent and/or recurrent historya of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc.), as judged by the investigator.
18. Not willing to avoid excessive sun exposure, steam baths, sauna, swimming and other strenuous activities for 14 days after Visit 2 to ensure good tissue regeneration.
19. Not willing to refrain from shaving the planned treatment sites or using skin care products on the planned treatment sites for at least 5 days prior to start of Visit 2.
20. Pronounced hairiness on the planned treatment sites that may negatively affect BE testing.
21. Known allergy/hypersensitivitya to any of the materials/supplies used during the study.
22. Presence of needle phobiaa.
23. Increased risk of thrombosis, e.g. personal or first degree relative(s) history of deep vein thrombosisa.
24. Not enough space on the thighs for the dOFM probe set-up (minimum length of 24 cm, 3 treatment sites with 4 dOFM probes –see Table 1).
a As declared by the subject or as reported in medical records.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Aim 1 Pilot Study: Assess dose-response relationship to define dose for the main study<br><br>Primary Aim 1 Main Study: Evaluate the ability of dOFM to assess bioequivalence (BE) between different diclofenac products

Secondary Outcome Measures

Name	Time	Method
Secondary Aim 1 Pilot Study: Test for absence of systemic cross-talk (systemic redistribution)<br><br>Secondary Aim 2 Pilot Study: Test for absence of lateral diffusion (Crosstalk between adjacent treatment sites)<br><br>Secondary Aim 3 Pilot Study: Compare non-equivalent test product with reference product