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Plaque PsoriasisPhase 2NCT03005964

Safety and Efficacy Study Comparing AM001 Cream, 7.5% to Vehicle Cream in the Treatment of Plaque Psoriasis

A Phase 2 study testing AM001 Cream, 7.5% in people with Plaque Psoriasis, run by AmDerma at 2 sites in Dominican Republic.

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

To compare the safety and efficacy profiles of AM001 Cream, 7.5% and its vehicle cream in the treatment of plaque psoriasis Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Plaque Psoriasis
What is being tested?
AM001 Cream, 7.5%
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
74 participants
Where
2 sitesDominican Republic
Study dates
Dec 2016to 4 Sep 2017
Phase
Phase 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

  • Subjects must provide written informed consent.
  • Subjects must be male or female, at least 18 years of age.
  • Subjects with a definite diagnosis of plaque psoriasis that is clinically active (for at least 3 months), involving at least 10% and up to 20% of the body surface area (not including the head [ scalp, face], hands, feet, and intertriginous areas).
  • Subjects with an Investigator's Global Assessment (IGA) of disease severity of at least moderate severity (score ≥ 3) as an overall assessment.
  • Subjects with a target lesion which has the following characteristics:
  • located on the extremities (i.e., arms or legs ) and has an area of ≥25 cm2;
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  • has a minimum plaque erythema of at least moderate severity (PASI grade ≥ 3);
  • has a minimum plaque scaling severity of at least moderate severity (PASI grade ≥ 3);
  • has a minimum plaque elevation of at least moderate severity (PASI grade ≥ 3);
  • If females of childbearing potential, the subject must have a negative urine pregnancy test, and must have been using an acceptable form of birth control for at least two months prior to Visit 1/Screening and are willing to continue birth control throughout the study.
  • Subjects must be willing and able to understand and comply with the requirements of the study, apply the assigned investigational product as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.
  • Subjects must be in good health, as confirmed by medical history and physical exam, and free from any clinically significant disease/condition, other than plaque psoriasis, that might interfere with the study evaluations.
  • Subjects must be willing to limit sun exposure overall. Subjects are prohibited from sunbathing or intentional tanning or intense sun exposure including the use of tanning booths/lights or other artificial UV light sources throughout the study.

Who cannot join

  • Female subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
  • Subjects who have a current diagnosis of guttate, pustular, inverse, exfoliative, or erythrodermic psoriasis.
  • Subjects who have a history of psoriasis unresponsive to topical treatments.
  • Subjects who have a history of a disorder that may interfere with the evaluation of plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis, cutaneous lymphoma, etc.).
  • Presence of pigmentation, extensive scarring, or pigmented lesions in the treatment areas, which could interfere with the rating of efficacy parameters.
  • Subjects with unstable medical disorders, life-threatening disease, or current malignancies.
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  • Subjects with clinically significant ECG or laboratory abnormalities at Visit 1/Screening (as determined by the Principal Investigator or designee).
  • Subjects who are immunosuppressed.
  • Subjects who have a history of allergy or a known hypersensitivity to any component of the investigational product.
  • Subjects who have been treated with any systemic steroids within the 4 weeks prior to the study entry (intranasal or inhaled corticosteroids are acceptable if kept constant throughout the study, and intra-articular steroid injections are permissible).
  • Subjects who have been treated with systemic or photo antipsoriatic therapies/drugs within 4 weeks prior to study entry including methotrexate, cyclosporine, acitretin and other oral retinoids, broadband or narrowband UVB, PUVA, home or professional tanning lights or other nonprescription UV light sources, photodynamic therapy (PDT), lasers, mycophenalate mofetil (MMF), thioguanine, hydroxyurea, sirolimus, azathioprine, 6-mercaptopurine (6-MP), or etanercept.
  • Subjects who have been treated with biologic therapy other than etanercept within 8 weeks prior to study entry, including adalibumab, infliximab, ustekinumab, golimumab, or rituximab. Vaccines will not be considered an exclusionary biologic treatment.
  • Subjects treated with any other biologic agent not listed here for psoriasis or psoriatic arthritis within 12 weeks.
  • Subjects who have been treated with any topical anti-psoriatic (e.g., salicylic acid, anthralin, tar, etc.,) any topical corticosteroid medications, topical retinoids (e.g., tazarotene, tretinoin), topical Vitamin D analogs (e.g., calcipotriene), topical immunosuppressants (e.g., tacrolimus, pimecrolimus) within 2 weeks prior to study entry.
  • Subjects who have been treated with lithium, antimalarial agents, or quinidine within the 4 weeks prior to study entry.
  • Subjects who have received radiation therapy and/or anti-neoplastic agents, or taken any immunosuppressant medication within 3 months prior to study entry.
  • Subjects who consume excessive amounts of alcohol, abuse drugs, or have any condition that would compromise compliance, in the investigator's opinion, with this protocol.
  • Subjects who have been treated with an investigational drug or investigational device within a period of 30 days prior to study entry, and within 120 days for investigational biologic agent.
  • Subjects who have been previously enrolled in this study.

Trial locations and contacts

2 sites in 1 country.

Dominican Republic2 sites

  • Instituto Dermatogical y Cirugia de Piel

    San Cristobal

  • Instituto Dermatologico Blanco Falette, MD

    Santo Domingo

Other trials in Dominican Republic

About this study

Official title: A Multi-Center, Double-Blind, Randomized, Vehicle- Controlled, Parallel-Group Study Comparing AM001 Cream, 7.5% to Vehicle Cream in the Treatment of Plaque Psoriasis

To compare the safety and efficacy profiles of AM001 Cream, 7.5% and its vehicle cream in the treatment of plaque psoriasis

Being tested
AM001 Cream, 7.5%, Vehicle Cream

What participants receive

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

  • AM001 Cream, 7.5%Drug

    Also called Potassium Dobesilate

    Active Cream

  • Vehicle CreamDrug

    Also called Placebo Cream

    Placebo

Study groups in NCT03005964
Study groupRoleWhat they receive
AM001 Cream, 7.5%ExperimentalA white to off-white Cream free from any foreign particles
Receives: Drug: AM001 Cream, 7.5%
Vehicle CreamPlacebo comparatorA white to off-white Cream free from any foreign particles.
Receives: Drug: Vehicle Cream

What is being measured

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

  1. Investigator's Global Assessment of Disease Severity (IGA)

    An assessment of disease severity will be performed at each study visit

    Measured: 12 weeks

Secondary outcomes (4)

  1. Target Lesion Psoriasis Area Severity Index (PASI)

    Erythema, Scaling and Plaque Elevation of the target lesion will be scored at baseline and at each subsequent study visit.

    Measured: 12 weeks

  2. Body Surface Area (BSA)

    The % BSA of all treatable psoriatic lesions and regions will be recorded at baseline and at week 12.

    Measured: 12 weeks

  3. Target Lesion Area

    The target lesion area will be measured at baseline and each-post-baseline visit.

    Measured: 12 weeks

  4. Dermatology Life Quality Index (DLQI)

    Measured at baseline and week 12

    Measured: 12 weeks

Timeline

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

  1. First posted30 Dec 2016 (estimated)
  2. Study startDec 2016
  3. Primary completion15 Aug 2017
  4. Study completion4 Sep 2017

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
74 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03005964
Sponsor's protocol ID
AD-AM001-001A
Status last verified
Oct 2018
First submitted
27 Dec 2016
Last updated
3 Oct 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AM001 Cream, 7.5% in people with Plaque Psoriasis, run by AmDerma at 2 sites in Dominican Republic.

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 13 inclusion and 19 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 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Dominican Republic. 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 phase mean?

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 of Disease Severity (IGA) (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 NCT03005964.

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 Oct 2018.

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