A study to investigate the bioequivalence of acyclovir cream using open flow microperfusion in the skin

• Register: EUCTR
• Last refreshed on: 13 November 2023
• Main ID: EUCTR2013-005062-19-AT
• Date of registration: 12/12/2014
• Prospective Registration: Yes
• Primary sponsor: Medical University of Graz - Division of Endocrinology and Metabolism
• Public title: A study to investigate the bioequivalence of acyclovir cream using open flow microperfusion in the skin
• Scientific title: An exploratory study to evaluate dermal open flow microperfusion’s (dOFM) ability to assess bioequivalence and non-bioequivalence of topical acyclovir formulations in healthy volunteers
• Date of first enrolment: 07/01/2015
• Target sample size: 56
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-005062-19
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Austria

Contacts

• Name: Dr. Stefan Korsatko
• Affiliation: Medical University of Graz

• Name: Dr. Stefan Korsatko
• Affiliation: Medical University of Graz

Key inclusion & exclusion criteria

Inclusion criteria:
1. Written informed consent must be obtained before any assessment is performed.
2. Male and female subjects 21 to 50 years of age inclusive and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
3. Able to communicate well with the investigator, to understand and comply with the requirements of the study.


Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 56
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations.
2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
3. Use of topical corticosteroids or systemic immunosuppression within the last 3 weeks (for topicals) or 3 months (systemic medication)
4. A history of clinically significant ECG abnormalities, or any of the following ECG abnormalities at screening or baseline.
• PR > 220 msec
• QRS complex > 120 msec
• Long QT syndrome
• QTcF > 430 msec males, > 450 females
5. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 10 mIU/mL).
6. Significant medical problems, including but not limited to the following: uncontrolled hypertension (=160 systolic /95 diastolic mm Hg), congestive heart failure [New York Heart Association status of class III or IV].
7. Screening total WBC count <3,500cells/µL, or platelets <140,000cells/µL or neutrophils ?2,000cells/µL or hemoglobin <12 g/dL / <13.5g/dL for female / male.
8. Active systemic infections during the last two weeks (exception: common cold) prior to enrollment.
9. A febrile illness within 72 hours, or major dental work within 8 days, prior to first dosing.
10. History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
11. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
12. Inability or unwillingness to undergo repeated catheterization and / or venipuncture (e.g., because of poor tolerability or lack of access to veins). Inability or unwillingness of having a skin biopsy if consent was given.
13. Any medical or psychiatric condition or clinical laboratory abnormalities which, in the Investigator’s opinion, would interfere with interpretation of study results and/or make the participant likely not to adhere to the protocol or complete the study per protocol.
14. History of venous thrombosis or known genetic predisposition to thromboembolic events
15. Subjects prone to keloid or hypertrophic scar formation or any wound healing disorder as visible by checking the vaccine insertion points on upper arm.
16. Fear of needles (belonophobia)
17. Recent (within the last three [3] years) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc).
18. Not willing to avoid excessive sun exposure, steam baths, sauna, swimming and other strenuous activities during the study to ensure good scarring



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

healthy volunteers (the medication that is used is authorized)

Therapeutic area: Not possible to specify

Intervention(s)

Trade Name: 5% Zovirax cream
Pharmaceutical Form: Cream
INN or Proposed INN: Aciclovir
Other descriptive name: ACICLOVIR
Concentration unit: % percent
Concentration type: equal
Concentration number: 5-

Trade Name: 5% Zovirax ointment
Pharmaceutical Form: Ointment
INN or Proposed INN: Aciclovir
Other descriptive name: ACICLOVIR
Concentration unit: % percent
Concentration type: equal
Concentration number: 5-

Trade Name: 5% Aciclostad cream
Pharmaceutical Form: Cream
INN or Proposed INN: Aciclovir
Other descriptive name: ACICLOVIR
Concentration unit: % percent
Concentration type: equal
Concentration number: 5-

Trade Name: 5% Aciclovir cream 1A Pharma
Pharmaceutical Form: Cream
INN or Proposed INN: Aciclovir
Other descriptive name: ACICLOVIR
Concentration unit: % percent
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

Main Objective: The overall aim of this clinical study is to investigate the ability of dermal open flow microperfusion to assess bioequivalence and non-bioequivalence of acyclovir formulations in the skin of healthy volunteers.

Secondary Objective: Not applicable

Timepoint(s) of evaluation of this end point: statistical analysis after active trial phase

Primary end point(s): - Area under the acyclovir concentration-time curve from 0-t hours (AUC0-t)
- Maximum observed acyclovir concentration (Cmax)

Secondary Outcome(s)

Secondary end point(s): Not applicable

Timepoint(s) of evaluation of this end point: Not applicable

Secondary ID(s)

FDA-BE1

Source(s) of Monetary Support

Medical University of Graz - Division of Endokrinology and Metabolism

Ethics review

Status: Approved
Approval date: 23/10/2014
Contact: