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Acne RosaceaPhase 2NCT03064438

Safety and Efficacy of ACU-D1 in the Treatment of Acne Rosacea

A Phase 2 study testing ACCU-D1 in people with Acne Rosacea, run by Accuitis, Inc. at 2 sites 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

The study evaluated the safety, tolerability, and efficacy of ACCU-D1 when applied twice daily for 12 weeks in adult participants with moderate to severe acne rosacea. Two-third of the participants received ACCU-D1 while one-third of the participants received vehicle control. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acne Rosacea
What is being tested?
ACCU-D1
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
2 sitesUnited States
Study dates
28 Nov 2017to 18 Jun 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Participant is male or non-pregnant and non-lactating female at least 18 years of age
  • Participant has a clinical diagnosis of stable papulopustular rosacea (type-2)
  • Participant has a total of ≥10 and ≤40 inflammatory lesions (papules, pustules, and nodules) on the face
  • Participant has ≤2 nodules on the face
  • Participant has an investigator's global assessment (IGA) score of ≥3
  • If the participant is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an approved effective method of birth control for the duration of the study
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  • Participant is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair evaluation of rosacea or which exposes the participant to an unacceptable risk by study participation
  • Participant is willing and able to follow all study instructions and to attend all study visits
  • Participant is able to comprehend and willing to sign an informed consent form

Who cannot join

  • Participant is pregnant, nursing, or planning to become pregnant during the duration of the study
  • Participant has used systemic glucocorticosteroids within 42 days prior to Visit 1 (inhaled and ocular glucocorticosteroids are permitted)
  • Participant has used systemic antibiotics within 28 days prior to Visit 1
  • Participant has used any topical glucocorticosteroids on the face within 28 days prior to Visit 1
  • Participant has used any prescription or over-the-counter product for the treatment of acne or rosacea within 14 days prior to Visit 1
  • Participant is currently using any therapy that, in the investigator's opinion, is a photosensitizer (for example, phenothiazines, amiodarone, quinine, thiazides, sulphonamides, quinolones, etc.)
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  • Participant currently has any skin disease (for example, psoriasis, atopic dermatitis, eczema), or condition (for example, actinic keratosis, photo-damage, sunburn, excessive hair, open wounds) that, in the investigator's opinion, might impair evaluation of rosacea or which exposes the subject to an unacceptable risk by study participation
  • Participant currently has, on the face, or has had on the face, any of the following within the specified period prior to Visit 1 that, in the investigator's opinion, might impair evaluation of rosacea or which exposes the subject to an unacceptable risk by study participation:
  • A cutaneous malignancy; 180 days
  • Experienced a sunburn; 14 days
  • Participant has facial hair, that in the investigator's opinion, might impair evaluation of rosacea or proper study medication application
  • Participant has a history of sensitivity to any of the ingredients in the study medications
  • Participant has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to Visit 1

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • DermResearch

    Austin, Texas, 78759

  • DS Research

    Louisville, Kentucky, 40421

Other trials in United States

About this study

Official title: A RANDOMIZED, DOUBLE-BLIND, VEHICLE CONTROLLED, PROOF-OF CONCEPT STUDY OF THE SAFETY AND EFFICACY OF ACU-D1 OINTMENT IN SUBJECTS WITH ACNE ROSACEA

The study evaluated the safety, tolerability, and efficacy of ACCU-D1 when applied twice daily for 12 weeks in adult participants with moderate to severe acne rosacea. Two-third of the participants received ACCU-D1 while one-third of the participants received vehicle control.

Conditions
Acne Rosacea
Being tested
ACCU-D1, Vehicle
Medical subject headings
Rosacea

What participants receive

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

  • ACCU-D1Drug

    ACCU-D1

  • VehicleDrug

    Placebo Comparator

Study groups in NCT03064438
Study groupRoleWhat they receive
ACU-D1 OintmentExperimentalTwice-daily application of ACU-D1 ointment to the face for 12 weeks.
Receives: Drug: ACCU-D1
ACU-D1 Ointment VehiclePlacebo comparatorTwice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks.
Receives: Drug: Vehicle

What is being measured

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

  1. Change From Baseline in Total Lesion Count at Week 12

    Total lesion count was the sum of counts of the following lesion types (face only): Papule - raised inflammatory lesions, <0.5 cm in diameter with no visible purulent material; Pustule - raised inflammatory lesions, <0.5 cm in diameter with visible purulent material; Nodule - any circumscribed, inflammatory mass ≥0.5 cm in diameter.

    Measured: Baseline, Week 12

Secondary outcomes (7)

  1. Percent Change From Baseline in Investigator's Global Assessment (IGA) Score at Weeks 2, 4, 8, and 12

    The IGA score is an ordered categorical value ranging from 0 (clear) to 4 (severe). A lower score indicated improvement in the condition.

    Score 0 (clear): no papules or pustules, no nodules, none or barely perceptible erythema

    Score 1 (near clear): very few (≤3) papules and/or pustules, no nodules, very mild erythema

    Score 2 (mild): few papules and pustules present, no nodules, mild erythema

    Score 3 (moderate): several papules and pustules are the predominant features, ≤2 nodules may be present, moderate erythema

    Score 4 (severe): numerous papules and pustules, multiple nodules may be present, severe erythema

    Measured: Baseline; Weeks 2, 4, 8, and 12

  2. Percentage of Participants Who Were Treatment Responders at Week 12

    Treatment responders were defined as participants who have either (1) 2 ordinal or more reductions in the IGA score from baseline or (2) an IGA score of 0 or 1.

    The IGA score is an ordered categorical value ranging from 0 (clear) to 4 (severe). A lower score indicated improvement in the condition.

    Score 0 (clear): no papules or pustules, no nodules, none or barely perceptible erythema

    Score 1 (near clear): very few (≤3) papules and/or pustules, no nodules, very mild erythema

    Score 2 (mild): few papules and pustules present, no nodules, mild erythema

    Score 3 (moderate): several papules and pustules are the predominant features, ≤2 nodules may be present, moderate erythema

    Score 4 (severe): numerous papules and pustules, multiple nodules may be present, severe erythema

    Measured: Baseline, Week 12

  3. Change From Baseline in Papule Lesions at Weeks 2, 4, 8, and 12

    Papule - raised inflammatory lesions, <0.5 cm in diameter with no visible purulent material

    Measured: Baseline; Weeks 2, 4, 8, and 12

  4. Change From Baseline in Pustule Lesions at Weeks 2, 4, 8, and 12

    Pustule - raised inflammatory lesions, <0.5 cm in diameter with visible purulent material

    Measured: Baseline; Weeks 2, 4, 8, and 12

  5. Change From Baseline in Nodule Lesions at Weeks 2, 4, 8, and 12

    Nodule - any circumscribed, inflammatory mass ≥0.5 cm in diameter

    Measured: Baseline; Weeks 2, 4, 8, and 12

  6. Change From Baseline in Papules + Pustules Lesions at Weeks 2, 4, 8, and 12

    Papules + pustules lesions were the sum of counts of papule (raised inflammatory lesions, <0.5 cm in diameter with no visible purulent material) and pustule (raised inflammatory lesions, <0.5 cm in diameter with visible purulent material) lesions.

    Measured: Baseline; Weeks 2, 4, 8, and 12

  7. Number of Participants With Adverse Events

    Number of participants reporting any adverse event including local tolerability of signs and symptoms of irritation, clinical laboratory safety tests, and vital signs.

    Measured: Baseline to Week 14

Timeline

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

  1. First posted27 Feb 2017
  2. Study start28 Nov 2017
  3. Primary completion5 Jun 2018
  4. Study completion18 Jun 2018

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
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03064438
Sponsor's protocol ID
ACU-D1
Status last verified
Aug 2021
First submitted
22 Feb 2017
Last updated
23 Aug 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jackson JM, Coulon R, Arbiser JL. Evaluation of a First-in-Class Proteasome Inhibitor in Patients With Moderate to Severe Rosacea. J Drugs Dermatol. 2021 Jun 1;20(6):660-664. doi: 10.36849/JDD.2021.5925.

    PubMed 34076401

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ACCU-D1 in people with Acne Rosacea, run by Accuitis, Inc. at 2 sites in United States.

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 9 inclusion and 13 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 23 Aug 2021. 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 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 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?

Yes. Results are posted in the registry (first posted 23 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Total Lesion Count at Week 12 (time frame: Baseline, Week 12). 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 NCT03064438, which also lists 1 linked publication.

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 23 Aug 2021.

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