Acne VulgarisPhase 1/2NCT01494285
Clinical Study to Evaluate Tolerability and Safety of ARK-E021 Foam and to Monitor Clinical Effect in Acne Vulgaris Patients
A Phase 1/2 study testing ARK-E021 5% and ARK-E021 10% in people with Acne Vulgaris, run by M. Arkin 1999 Ltd. at 3 sites in Israel.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled, 3-arm, parallel-group, ambulatory safety and efficacy study of ARK-E021 topical foam of 5% and 10% in subjects with mild to moderate acne vulgaris. Read more about this study
- Who is it for?
- Ages 12 to 40 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- ARK-E021 5% and ARK-E021 10%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 3 sitesIsrael
- Study dates
- Jun 2012to Oct 2013
- Phase
- Phase 1/2
- 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 12 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Main Inclusion Criteria:
- Patient is male or female between the ages of 12 to 40.
- A clinical diagnosis of acne vulgaris with facial involvement.
- Minimum of 15 inflammatory lesions on the face (papules and/ or pustules)but not more than 40.
- Existence of non-inflammatory lesions on the face (opened and/or closed comedones).
- A score of ≥2 (moderate) on the investigator's global assessment scale.
- Use of non oral contraceptives in female of childbearing potential during the study.
- No known medical conditions that, in the Investigator's opinion could interfere with study participation.
- Patient is willing and able to comply with all the requirement of the study protocol.
- Patient is willing and able to give written informed consent prior to participation in the study.
Main Exclusion Criteria:
- Acne conglobata, acne fulminans, secondary acne (chloracne, drug induced acne), or severe acne requiring systemic treatment.
- One or more active nodule/cyst acne on the face (inactive lesions allowed).
- Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.
- Participation in another investigational drug trial within 30 days prior to study entry.
- Concomitant medication:
- Use of systemic steroids, systemic antibiotics, systemic treatment for acne vulgaris, systemic anti-inflammatory agents within 4 weeks prior to baseline or during the study.
- Use of topical steroids, topical antibiotics, topical treatment for acne vulgaris, topical anti-inflammatory agents within 2 weeks prior to baseline or during the study.
- Treatment for acne with isotretinoin or isotretinoin derivatives within 12 months prior to study entry.
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
HaEmek Medical Center
Afula
Meir Medical Center
Kfar Saba
Souraski Medical Center
Tel Aviv
About this study
Official title: Multicenter, Randomized, Double-blind, Placebo-controlled, 3-arm, Parallel-group, Ambulatory Safety and Efficacy Study of ARK-E021 Topical Foam of 5% and 10% in Subjects With Mild to Moderate Acne Vulgaris.
This is a multicenter, randomized, double-blind, placebo-controlled, 3-arm, parallel-group, ambulatory safety and efficacy study of ARK-E021 topical foam of 5% and 10% in subjects with mild to moderate acne vulgaris.
Read the detailed description
This is a phase I/II prospective, multicenter, randomized, double blind, placebo controlled, parallel group, dose range finding clinical study to evaluate the safety, tolerability and preliminary efficacy of ARK-E021 foam for treatment of acne vulgaris.
It is anticipated that the study will be conducted at the listed Medical Centers as well as out-patient clinics at the community.
Approximately 144 male and female subjects with mild to moderate facial acne vulgaris will be enrolled in this study. Following satisfaction of the entry criteria and screening procedures, subjects will be randomized to either 5% or 10% topical foam (ARK-E021) or placebo foam. Subjects will apply the study medication once daily on the face at bedtime for 12 weeks followed by a post-treatment follow up visit 4 weeks after end of treatment. The first dose will be applied in the presence of the study investigator or his assignee. Subsequent applications will be made by the patient.
Safety will be monitored throughout the study duration. Efficacy will be assessed by facial lesion counts and by the investigator global evaluation of acne severity at baseline and at weeks 3, 6, 9, 12 and 16.
- Conditions
- Acne Vulgaris
- Being tested
- ARK-E021 5%, ARK-E021 10%, Placebo
- Keywords
- Acne Vulgaris, Topical, Foam
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARK-E021 5%Drug
Also called Not yet marketed
Topically applied once daily at bedtime
ARK-E021 10%Drug
Also called Not yet marketed
Topically applied once daily at bedtime
PlaceboDrug
Also called Not marketed
Topically applied once daily at bedtime
| Study group | Role | What they receive |
|---|---|---|
| ARK-E021 5% foam | Experimental | Not described Receives: Drug: ARK-E021 5% |
| ARK-E021 10% foam | Experimental | Not described Receives: Drug: ARK-E021 10% |
| Placebo foam | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of ARK-E021 topical foam in subjects with acne vulgaris.
Subject safety will be assessed following treatment using measurements of the following variables:
- Physical examination.
- Vital Signs (HR, BP, Body temperature).
- Adverse events recording.
- Concomitant medications.
Measured: Baseline through week 16.
To evaluate the efficacy of ARK-E021 topical foam in subjects with acne vulgaris.
Subject efficacy will be assessed following treatment using measurements of the following variables:
- Lesion count (inflammatory/non inflammatory and total).
- Investigator global assessment (IGA; grade 0-4).
- Lesion documentation by photographs (optional).
Measured: Baseline through week 16.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2011 (estimated)
- Study startJun 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- M. Arkin 1999 Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Vyne Therapeutics Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01494285
- Sponsor's protocol ID
- MA1001
- Status last verified
- Dec 2013
- First submitted
- 15 Dec 2011
- Last updated
- 3 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-blind, Placebo-controlled, 3-arm, Parallel-group, Ambulatory Safety and Efficacy Study of ARK-E021 Topical Foam of 5% and 10% in Subjects With Mild to Moderate Acne Vulgaris.
- ClinicalTrials.gov ID
- NCT01494285
- Acronym / sponsor ID
- MA1001
- Conditions
- Acne Vulgaris
- Keywords
- Acne Vulgaris, Topical, Foam
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- M. Arkin 1999 Ltd.University, hospital or other
- Collaborators
- Vyne Therapeutics Inc.
- Study start
- Jun 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 16 Dec 2011 (estimated)
- 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 is a multicenter, randomized, double-blind, placebo-controlled, 3-arm, parallel-group, ambulatory safety and efficacy study of ARK-E021 topical foam of 5% and 10% in subjects with mild to moderate acne vulgaris.
Detailed description
This is a phase I/II prospective, multicenter, randomized, double blind, placebo controlled, parallel group, dose range finding clinical study to evaluate the safety, tolerability and preliminary efficacy of ARK-E021 foam for treatment of acne vulgaris.
It is anticipated that the study will be conducted at the listed Medical Centers as well as out-patient clinics at the community.
Approximately 144 male and female subjects with mild to moderate facial acne vulgaris will be enrolled in this study. Following satisfaction of the entry criteria and screening procedures, subjects will be randomized to either 5% or 10% topical foam (ARK-E021) or placebo foam. Subjects will apply the study medication once daily on the face at bedtime for 12 weeks followed by a post-treatment follow up visit 4 weeks after end of treatment. The first dose will be applied in the presence of the study investigator or his assignee. Subsequent applications will be made by the patient.
Safety will be monitored throughout the study duration. Efficacy will be assessed by facial lesion counts and by the investigator global evaluation of acne severity at baseline and at weeks 3, 6, 9, 12 and 16.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ARK-E021 5% foam | Experimental | Drug: ARK-E021 5% |
| ARK-E021 10% foam | Experimental | Drug: ARK-E021 10% |
| Placebo foam | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| ARK-E021 5%Also: Not yet marketedTopically applied once daily at bedtime | Drug | ARK-E021 5% foam |
| ARK-E021 10%Also: Not yet marketedTopically applied once daily at bedtime | Drug | ARK-E021 10% foam |
| PlaceboAlso: Not marketedTopically applied once daily at bedtime | Drug | Placebo foam |
Primary outcome
To evaluate the safety and tolerability of ARK-E021 topical foam in subjects with acne vulgaris.
Time frame: Baseline through week 16.
Subject safety will be assessed following treatment using measurements of the following variables: * Physical examination. * Vital Signs (HR, BP, Body temperature). * Adverse events recording. * Concomitant medications.
To evaluate the efficacy of ARK-E021 topical foam in subjects with acne vulgaris.
Time frame: Baseline through week 16.
Subject efficacy will be assessed following treatment using measurements of the following variables: * Lesion count (inflammatory/non inflammatory and total). * Investigator global assessment (IGA; grade 0-4). * Lesion documentation by photographs (optional).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2013.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ARK-E021 5% and ARK-E021 10% in people with Acne Vulgaris, run by M. Arkin 1999 Ltd. at 3 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 3 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To evaluate the safety and tolerability of ARK-E021 topical foam in subjects with acne vulgaris. (time frame: Baseline through week 16.). 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?
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 3 Dec 2013.