Moderate to Severe Papulopustular RosaceaPhase 1/2NCT03050086

Open Label Phase 2 Feasibility Study of BPX-04 Topical Minocycline Gel in Rosacea

A Phase 1/2 study testing BPX-04 1% minocycline topical gel and BPX-04 2% minocycline topical gel in people with Moderate to Severe Papulopustular Rosacea, run by BioPharmX, Inc. at 1 site in United States.

Completed

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

Official record

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Trial summary

An open label feasibility study using BPX-04 topical minocycline gel in papulopustular rosacea. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Moderate to Severe Papulopustular Rosacea
What is being tested?: BPX-04 1% minocycline topical gel and BPX-04 2% minocycline topical gel
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 29 Mar 2017to 19 Jun 2018
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female subjects ≥18 years of age at the time of consent.
Subjects do not have any medical conditions, other than rosacea, that in the opinion of the investigator, put the subject at unacceptable risk or could interfere with study assessments or integrity of the data.
A clinical diagnosis of moderate to severe (Grade 3 or 4) facial rosacea (papulopustular (Subtype 2) or mixed erythematotelangiectatic (Subtype 1) and papulopustular (Subtype 2)) as determined by the Investigator's Global Assessment (IGA) at Visit 1/Screening.
Female subjects of childbearing potential (including pre-puberty) are willing to use effective contraceptive method for at least 28 days before baseline (Day 0) and at least 28 days after the last study product administration or have a sterilized or same-sex partner for the duration of the study. Hormonal contraceptives must be on a stable dose for at least 12 weeks before baseline (Day 0). Subjects using low dose oral contraceptives must use a second form of birth control (e.g., barrier method such as condoms with spermicide).
Note: Female subjects of non-childbearing potential are defined as follows:
Female subjects who have had surgical sterilization (hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation);

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Female subjects who have had a cessation of menses for at least 12 months and a follicle-stimulating hormone (FSH) test confirming non-childbearing potential (refer to the central laboratory reference range for menopausal women) or cessation of menses for at least 24 months without FSH levels confirmed;
Female subjects of childbearing potential must have a negative urine pregnancy test at screening and baseline (Day 0).
Treatment with hormonal therapy must be on a stable dose and frequency for at least 12 weeks before baseline (Day 0) and must remain stable throughout the study.
Subjects who use make-up, facial moisturizers, creams, lotions, cleansers and/or sunscreens must have used the same product brands/types for a minimum period of 14 days prior to baseline (Day 0), must agree not to change brand/type or frequency of use throughout the study and must agree not to use make-up, facial moisturizers, creams, lotions, cleansers and/or sunscreens on the clinic visit days before the visit.
Subjects must be capable of giving informed consent and the written informed consent must be obtained prior to any study-related procedures.

Who cannot join

Have a history of skin disease, presence of skin condition or excessive facial hair the PI believes would interfere with the study
Have moderate or severe rhinophyma, severe telangiectasia or plaque-like facial edema
Have rosacea conglobata or fulminans, corticosteroid induced rosacea or facial erythrosis other than rosacea
Have ocular rosacea of a severity that requires systemic treatment
Have a history of any adverse reaction to minocycline or other tetracycline class antibiotic
Have a clinically significant chemistry or hematology value at baseline or have an ALT or AST at screening that is greater than or equal to 2x normal

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Have conditions or factors that the PI believes may affect the response of the skin or the interpretation of the results
Participated in any clinical study with exposure to any investigational treatment or product within the previous 30 days, or plan on concurrent participation in other studies
Have used on the face an OTC topical medication for the treatment of rosacea within 4 weeks prior to baseline.
Have used prescription topical (on the face) or oral antibiotics or corticosteroids within 4 weeks prior to baseline.
Have had a facial procedure such as chemical peel, laser, microdermabrasion within 8 weeks prior to baseline
Have received photodynamic therapy or phototherapy with blue or red light within 12 weeks prior to baseline
Have used an oral retinoid within 6 months or a topical retinoid within 3 months prior to baseline
Current drug or alcohol abuse
Female subject who is breastfeeding, pregnant or who is planning a pregnancy during the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Study Center
San Diego, California, 92123

Other trials in United States

About this study

Official title: An Open Label Phase 2 Feasibility Study to Assess the Safety and Efficacy of BPX-04 Minocycline Topical Gel in Treatment of Moderate to Severe Papulopustular Rosacea (BPX-01-C05)

An open label feasibility study using BPX-04 topical minocycline gel in papulopustular rosacea.

Conditions: Moderate to Severe Papulopustular Rosacea
Being tested: BPX-04 1% minocycline topical gel, BPX-04 2% minocycline topical gel, BPX-04 vehicle topical gel

What participants receive

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

BPX-04 1% minocycline topical gelDrug
once daily administration of topical minocycline gel to face
BPX-04 2% minocycline topical gelDrug
once daily administration of topical minocycline gel to face
BPX-04 vehicle topical gelDrug
once daily administration of topical minocycline gel to face

Study groups in NCT03050086
Study group	Role	What they receive
BPX-04 1% Minocycline Topical Gel	Experimental	once daily topical administration of 1% minocycline gel to the face Receives: Drug: BPX-04 1% minocycline topical gel
BPX-04 2% Minocycline Topical Gel	Experimental	once daily topical administration of 2% minocycline gel to the face Receives: Drug: BPX-04 2% minocycline topical gel
BPX-01 Vehicle Topical Gel	Placebo comparator	once daily topical administration of vehicle gel to the face Receives: Drug: BPX-04 vehicle topical gel

What is being measured

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

Investigator's Global Assessment
papules, pustules and erythema
Measured: 12 weeks

Secondary outcomes (1)

Lesion count
papules and pustules
Measured: 12 weeks

Timeline

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

29 Mar 201719 Jun 2018

First posted10 Feb 2017
Study start29 Mar 2017
Primary completion19 Jun 2018
Study completion19 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Moderate to Severe Papulopustular RosaceaStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03050086
Sponsor's protocol ID: BPX-01-C05
Status last verified: Jan 2019
First submitted: 8 Feb 2017
Last updated: 31 Jan 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label Phase 2 Feasibility Study to Assess the Safety and Efficacy of BPX-04 Minocycline Topical Gel in Treatment of Moderate to Severe Papulopustular Rosacea (BPX-01-C05)
ClinicalTrials.gov ID: NCT03050086
Acronym / sponsor ID: BPX-01-C05
Conditions: Moderate to Severe Papulopustular Rosacea
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: BioPharmX, Inc.Industry (pharma, biotech, devices)
Study start: 29 Mar 2017 (actual)
Primary completion: 19 Jun 2018 (actual)
Study completion: 19 Jun 2018 (actual)
First posted: 10 Feb 2017 (actual)
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.

An open label feasibility study using BPX-04 topical minocycline gel in papulopustular rosacea.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
BPX-04 1% Minocycline Topical Gel	Experimental	Drug: BPX-04 1% minocycline topical gelonce daily topical administration of 1% minocycline gel to the face
BPX-04 2% Minocycline Topical Gel	Experimental	Drug: BPX-04 2% minocycline topical gelonce daily topical administration of 2% minocycline gel to the face
BPX-01 Vehicle Topical Gel	Placebo comparator	Drug: BPX-04 vehicle topical gelonce daily topical administration of vehicle gel to the face

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Male or female subjects ≥18 years of age at the time of consent.
Subjects do not have any medical conditions, other than rosacea, that in the opinion of the investigator, put the subject at unacceptable risk or could interfere with study assessments or integrity of the data.
A clinical diagnosis of moderate to severe (Grade 3 or 4) facial rosacea (papulopustular (Subtype 2) or mixed erythematotelangiectatic (Subtype 1) and papulopustular (Subtype 2)) as determined by the Investigator's Global Assessment (IGA) at Visit 1/Screening.
Female subjects of childbearing potential (including pre-puberty) are willing to use effective contraceptive method for at least 28 days before baseline (Day 0) and at least 28 days after the last study product administration or have a sterilized or same-sex partner for the duration of the study. Hormonal contraceptives must be on a stable dose for at least 12 weeks before baseline (Day 0). Subjects using low dose oral contraceptives must use a second form of birth control (e.g., barrier method such as condoms with spermicide).
Female subjects of childbearing potential must have a negative urine pregnancy test at screening and baseline (Day 0).

Key exclusion criteria (15 listed)

Have a history of skin disease, presence of skin condition or excessive facial hair the PI believes would interfere with the study
Have moderate or severe rhinophyma, severe telangiectasia or plaque-like facial edema
Have rosacea conglobata or fulminans, corticosteroid induced rosacea or facial erythrosis other than rosacea
Have ocular rosacea of a severity that requires systemic treatment
Have a history of any adverse reaction to minocycline or other tetracycline class antibiotic

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
BPX-04 1% minocycline topical gelonce daily administration of topical minocycline gel to face	Drug	BPX-04 1% Minocycline Topical Gel
BPX-04 2% minocycline topical gelonce daily administration of topical minocycline gel to face	Drug	BPX-04 2% Minocycline Topical Gel
BPX-04 vehicle topical gelonce daily administration of topical minocycline gel to face	Drug	BPX-01 Vehicle Topical Gel

Primary outcome

Investigator's Global Assessment
Time frame: 12 weeks
papules, pustules and erythema

1 secondary outcome

Lesion count
Time frame: 12 weeks

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 31 Jan 2019.
Individual participant dataSharing planned: No

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.

AnnaMarie Daniels study director

BioPharmX, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 inclusion and 15 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 31 Jan 2019. 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 United States. 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?

Investigator's Global Assessment (time frame: 12 weeks). 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 NCT03050086.

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 31 Jan 2019.