This is a list of our most frequently asked questions. Click on the question to see the answer.  

An investigator initiated study (abbreviated IIS) is a research effort where an investigator and/or sponsor is seeking support from Aclaris Therapeutics, Inc. ("Aclaris") to conduct a clinical investigation.

An investigator is the individual who conducts the investigation (i.e. under whose immediate direction the investigational drug is administered or dispensed to a subject). An investigator of an IIS assumes the responsibilities of, and must comply with, FDA regulations applicable to both a sponsor and an investigator. These responsibilities include the submission and maintenance of an IND, regulatory responsibilities and manage the conduct of the study.

A sponsor takes responsibility for and initiates a clinical investigation. A sponsor can be an individual, a collaborative group of investigators, governmental agency, academic institution, pharmaceutical company, private organization, or other organization (e.g. patient advocacy organization).

Aclaris may support an IIS with drug product and/or funding, and materials (including Aclaris information, placebo, or other medicinal products necessary for the research).

Our current areas of interest are dermatologic conditions such as: seborrheic keratosis; common warts; alopecia areata; and vitiligo.

  • Clinical studies of Aclaris Therapeutics marketed drugs for approved or investigational uses

  • Clinical studies of Aclaris Therapeutics investigational drug product

  • Observational studies of real-world experience (retrospective, prospective, EHR, database or epidemiology, patient reported experience) in areas of interest

  • Non-clinical studies (animal or laboratory)

  • Subpopulation information for seborrheic keratosis (abbreviated SK) and warts

    • Smooth or flat seborrheic keratosis
    • Fitzpatrick skin types (III-VI) skin of color
    • SK lesions outside the facial region (e.g. trunk, extremities, etc.)
    • Combination treatment with dermatology interventions
    • Dermatosis papulosa nigra (DPN)
    • Molluscum contagiosum

Compassionate Use

  • Possess the scientific, technical and operational capabilities to conduct the study, including adequately trained staff and statistical support

  • Submit a well-designed protocol and budget. Please submit well defined study hypothesis, primary and secondary endpoints

  • Develop and maintain the case report forms

  • Initiate and monitor the study

  • Comply with any and all pertinent laws, regulations, and guidelines (e.g. IND)

  • Comply with any and all requirements of institution(s) with which they are associated or in which research will occur (e.g. IRB)

  • Report safety data to regulatory authorities (FDA), the IRB and Aclaris

  • Provide periodic ongoing study updates to Aclaris

  • Submit a written report of the final study results to Aclaris

  • Submit abstract/publication to Aclaris two weeks before submission to a journal or meeting

  • Publish the results in a scientific journal and provide a copy of the manuscript to Aclaris

  • Provide approved support as outlined in the legal agreement in a timely manner

  • Provide any scientific/medical feedback to the Investigator-initiator at any point in time regarding the proposal, the protocol, or any aspect of study conduct where Aclaris has a concern about the scientific integrity of the study or patient well-being

  • An IIS concept proposal initially and finalized as a protocol

  • A fully executed IIS agreement between the sponsor/investigator and Aclaris

  • A fully executed safety data exchange agreement between the sponsor/investigator and Aclaris

  • An IRB or health authority approval

  • Patient Consent form

  • Curriculum vitae of investigator or sub-investigators

  • Everything begins with you registering in the Aclaris IIS portal

  • Once you have registered, you will then be able to submit research proposals to Aclaris

  • Throughout this step and all phases of the process, the system will automatically notify you about various documentation requirements, such as your curriculum vitae, budget requests (if applicable), and milestone updates

  • Once you have submitted a proposal, it will be reviewed by the Aclaris IIS Committee. If there are any questions, you will receive notification from Aclaris for clarification or additional information

  • After this initial review and any needed follow up is complete, the proposal will move into our corporate IIS proposal review process where Aclaris medical personnel for the given product/therapy area will review the proposal and make an initial decision; this decision could be approval, decline, or a request for additional information

  • If the proposal is approved, the process then moves into protocol development and review; once you have completed a draft protocol, Aclaris medical personnel will review the protocol in a similar fashion as the initial proposal review with a primary focus on the scientific integrity of the study design and overall patient well-being; the end result will be a similar set of decision outcomes as the initial proposal

  • If you submit a full draft protocol with the initial proposal (not required), then both the proposal and protocol review would occur in one review step versus two

  • Once the protocol is approved, Aclaris will then finalize contractual terms of the support being provided and expectations for you as the study sponsor

  • After the contract is finalized and all supporting documentation has been obtained, you will then be ready to start the conduct of the study

  • Throughout study conduct, the system will notify you automatically for study progress reports and supporting documentation for any support payments, product shipment requests, etc.

  • Once the study enrollment is complete, we will then move into closing out the study and enter the publications phase of the study (final deliverables from the study as defined in the contract)

  • Per the contractual terms, Aclaris will request review of any defined deliverables from the study (abstracts, publications, etc.)

  • At any point, you will be able to go into your account in the system and see the status of your proposal(s) and/or study(s)

  • The first step is to click on the Submit a Proposal button

  • This will take you to the first of two parts of the proposal submission process

  • Part one is the online form that basically captures categorical information about your proposal; this information is collected directly in the system to enable the proper internal routing and classification of the proposal

  • Part two of the process captures the detail of the actual study you are proposing, including aspects of the overall study design, target population, statistical analysis plan, etc.

    • There are two options in completing part two of the process:

      • 1) You can download and complete the provided template or

      • 2) You can submit your own full protocol

    • Regardless of which option you choose, you will attach the completed template or protocol into the system and the file will become part of your proposal file that will be reviewed by Aclaris personnel

  • After attaching the template or protocol, you can also submit any other needed attachments at this point or later in the process; this could include an itemized budget for funding support requested, your curriculum vitae, current healthcare license, or other study related documentation

  • After you have submitted your full proposal, you will receive an automatic notification from the system via e-mail confirming success of your submission

  • At any time, you can then login and check the status of the proposal, add additional attachments to the system, or review correspondence that you have received from Aclaris

  • Conduct a high-quality ethical study

  • Register the protocol on a public web site (e.g. ClinialTrials.gov, ICTRP)

  • Complete required documentation in a timely manner

  • Meet applicable deadlines as defined in the legal agreement

  • Ensure patient safety

  • Report any safety issues and adverse events in a timely fashion as defined in the legal agreement

  • Disclose any affiliation or financial conflicts of interest

  • Ensure financial transparency

  • Ensure patient confidentiality

  • Publish study results in an appropriate, transparent and timely manner

  • Ask questions whenever needed

  • Professional interactions with Aclaris employees who ensure patient safety is of paramount importance

  • Timely responses to any inquiries or requests coming from the sponsor, including decisions on completed proposals

  • No involvement of Aclaris sales or marketing employees in any aspect of an IIS

  • Compliance with data protection laws with respect to the personally identifiable information of the sponsors/investigators

  • An easy to use information portal

  • Once reviewed for completeness, all proposals go through a scientific review process that is made up of key medical personnel for the given product/therapy area

  • Decisions are made based primarily on the overall scientific rationale of the proposal; additional considerations include alignment with Aclaris' areas of scientific interest, qualifications of the investigator-sponsor, availability of internal funding resources, a market assessment of any funding requested, and evaluation if similar research is already being conducted or has been conducted.