AzTrials
AzTrials

Dermatologic DisordersFDA_BE1NCT02711267

Bioequivalence of Topical Acyclovir in Healthy Volunteers

A study testing 5% Zovirax® cream, 5% Aciclostad cream and 5% Aciclovir cream 1A Pharma in people with Dermatologic Disorders, run by Medical University of Graz at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 21 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Dermatologic Disorders
What is being tested?
5% Zovirax® cream, 5% Aciclostad cream and 5% Aciclovir cream 1A Pharma
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteAustria
Study dates
Jan 2014to Aug 2015
Phase
Interventional
Are there results?
None posted in the registry

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 21 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Written informed consent must be obtained before any assessment is performed.
  • 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.
  • Able to communicate well with the investigator, to understand and comply with the requirements of the study.

Who cannot join

  • 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.
  • History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
  • Use of topical corticosteroids or systemic immunosuppression within the last 3 weeks (for topicals) or 3 months (systemic medication)
  • 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
Show all 23Show fewer
  • Long QT syndrome
  • QTcF > 430 msec males, > 450 females
  • 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 (human chorionic gonadotropin) laboratory test (> 10 mIU/mL).
  • 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].
  • 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.
  • Active systemic infections during the last two weeks (exception: common cold) prior to enrollment.
  • A febrile illness within 72 hours, or major dental work within 8 days, prior to first dosing.
  • History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
  • A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
  • 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.
  • 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.
  • History of venous thrombosis or known genetic predisposition to thromboembolic events
  • Subjects prone to keloid or hypertrophic scar formation or any wound healing disorder as visible by checking the vaccine insertion points on upper arm.
  • Fear of needles (belonephobia)
  • Recent (within the last three [3] years) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc).
  • Not willing to avoid excessive sun exposure, steam baths, sauna, swimming and other strenuous activities during the study to ensure good scarring.
  • Not willing to refrain from use of skin care products applied on application sites for at least 5 days prior to start of Visit 2.

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Medical University Graz

    Graz, Styria, 8036

Other trials in Austria

About this study

Official 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

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.

Read the detailed description

This will be a single center, open label, exploratory research study to evaluate the BE of already marketed formulations of acyclovir in dermal interstitial fluid (ISF) in healthy volunteers using dOFM. The study will be conducted at the Clinical Research Center at the Medical University Graz. dOFM represents the most reliable way to sample interstitial fluid from skin, since it provides diluted but otherwise unchanged dermal interstitial fluid. To assess BE and non-BE, we have designed the experiments in such a way that each subject can serve as its own control. Each subject will have two sets of BE and non-BE pairs in parallel. This study is designed to test dOFM, a new sampling method that allows measurement of skin penetration. Measurement of skin penetration enables the reduction of the impact of inter-subject variability and therefore decreases the number of subjects needed to achieve statistical significance.

Being tested
5% Zovirax® cream, 5% Aciclostad cream, 5% Aciclovir cream 1A Pharma, 5% Zovirax Cold Sore Cream, 5% Zovirax® cream (Austria)
Keywords
Open Flow Microperfusion
Medical subject headings
Skin Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 5% Zovirax® creamDrug

    Also called Aciclovir

    (manufactured by GlaxoSmithKline Pharma in Canada, distributed in the USA by Valeant Pharmaceuticals North America LCC, Bridgewater,NJ 08807)

  • 5% Aciclostad creamDrug

    Also called Aciclovir

    (STADA Arzneimittel GmbH, Vienna, Austria)

  • 5% Aciclovir cream 1A PharmaDrug

    Also called Aciclovir

    (1A Pharma GmbH, Vienna, Austria)

  • 5% Zovirax Cold Sore CreamDrug

    Also called Aciclovir

    (GlaxoSmithKline Consumer Health Care, Brendfort, UK; Marketing authorization holder: Beeham Group PLC, Brendfort, UK)

  • 5% Zovirax® cream (Austria)Drug

    Also called Aciclovir

    (GlaxoSmithKline Pharma GmbH, Vienna, Austria)

  • OFMProcedure or surgery

    Also called Open Flow Microperfusion

    Sampling method for interstitial fluid

  • OFM ProbeDevice

    Also called 'DEA15003' (linear type, 0.5mm OD, 15mm open mesh)

    Sampling probe used during OFM

  • OFM PumpDevice

    Also called 'MPP102' (wearable, operates 3 to 6 probes)

    Pump used to operate OFM probes

Study groups in NCT02711267
Study groupRoleWhat they receive
Phase 1: Optimization StudyExperimental6 subjects will be included in this study, each with 3 application sites on the arm and 3 on the leg. 2 dOFM probes (OFM Probe) will be implanted per site resulting in 12 dOFM probes per subject (operated by OFM pump). On each the arm and the leg the proximal and distal site of the 3 adjacent sites will be treated by 5% Zovirax® cream. The central site on arm and leg will be left untreated in order to test a potential lateral carry-over of acyclovir from one application site to the other. Blood samples will be taken to test for uptake into the blood stream and redistribution to other application sites.
Receives: Drug: 5% Zovirax® cream; Procedure: OFM; Device: OFM Probe; Device: OFM Pump
Phase 2: Formulation StudyExperimental6 subjects will be included in this study, each with 3 application sites on the arm and 3 on the leg. 2 dOFM probes will be implanted per site resulting in 12 dOFM probes per subject. Different topical 5% acyclovir formulations currently available on the market will be tested. One application site on the arm and one on the leg will be used for U.S. Zovirax® cream 5% application. The remaining two application sites on the arm and the remaining 2 on the leg will be used to randomly administer two of the remaining formulations (5% Aciclostad cream, 5% Aciclovir cream 1A Pharma, 5% Zovirax® cream (Austria), 5% Zovirax Cold Sore Cream) according to an application pattern.
Receives: Drug: 5% Zovirax® cream; Drug: 5% Aciclostad cream; Drug: 5% Aciclovir cream 1A Pharma; Drug: 5% Zovirax Cold Sore Cream; Drug: 5% Zovirax® cream (Austria); Procedure: OFM; Device: OFM Probe; Device: OFM Pump
Phase 3: Pilot BE studyExperimental4 subjects will be included in the pilot BE study with 3 application sites on each leg. 2 dOFM probes will be implanted per site resulting in 12 dOFM probes per subject. One reference drug product (R) and one test drug product (T) will be applied on the application sites in order to test for BE between duplicate sites with R applied, and to test for non-BE between application sites with R and T applied.
Receives: Drug: 5% Zovirax® cream; Drug: 5% Aciclovir cream 1A Pharma; Procedure: OFM; Device: OFM Probe; Device: OFM Pump
Phase 4: Main BE StudyExperimental20 subjects will be included in the pilot BE study with 3 application sites on each leg. 2 dOFM probes will be implanted per site resulting in 12 dOFM probes per subject. One reference drug (R) and one test drug (T) will be applied on the application sites in order to test for BE between duplicate sites with R applied and to test for non-BE between application sites with R and T applied.
Receives: Drug: 5% Zovirax® cream; Drug: 5% Aciclovir cream 1A Pharma; Procedure: OFM; Device: OFM Probe; Device: OFM Pump

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUC

    Area under the dOFM acyclovir concentration curve (AUC) during 12/36h of OFM-Sampling (post-dose)

    Measured: during 12-36h of OFM-Sampling (post-dose)

  2. CMAX

    Maximum observed dOFM acyclovir concentration (CMAX) during 12/36h of OFM-Sampling (post-dose)

    Measured: during 12-36h of OFM-Sampling (post-dose)

Secondary outcomes (2)

  1. dOFM acyclovir concentration

    Measured: during 12-36h of OFM-Sampling (post-dose)

  2. TMAX

    Time to reach maximum dOFM acyclovir concentration (TMAX)

    Measured: during 12-36h of OFM-Sampling (post-dose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2016 (estimated)
  2. Study startJan 2014
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

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 N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02711267
Sponsor's protocol ID
FDA_BE1
Acronym
FDA_BE1
Status last verified
Mar 2016
First submitted
29 Jul 2015
Last updated
17 Mar 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing 5% Zovirax® cream, 5% Aciclostad cream and 5% Aciclovir cream 1A Pharma in people with Dermatologic Disorders, run by Medical University of Graz at 1 site in Austria.

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 23 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: finished, as of the sponsor's last update on 17 Mar 2016. 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 Austria. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

AUC (time frame: during 12-36h of OFM-Sampling (post-dose)). 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 NCT02711267.

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 17 Mar 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in