Bovine Atelocollagen Skin Sensitization Test

February 8, 2022 updated by: AscentX Medical, Inc.
Bovine atelocollagen skin testing of healthy adult volunteers to investigate the potential of allergy to atelocollagen medical device implants

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Day 01: Receive 0.1 mL intradermal injection of atelocollagen skin test into left volar forearm.

Day 15: Receive 2nd intradermal injection of 0.1 mL atelocollagen skin test into right volar forearm (14 days after 1st injection).

Day 45: Final assessment of both injection sites (30 days after 2nd injection)

Note: ALL injection sites will be assessed clinically at 30 minutes (for observational purposes) and at 72 hours (to determine response) after each injection. Visit windows for 72 hour assessments, and Day 15 and Day 45 visits can occur up to 96 hours (4 days) after target time.

Study Type

Interventional

Enrollment (Anticipated)

550

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Chula Vista, California, United States, 91910
        • Recruiting
        • Dermatology Institute
        • Contact:
        • Principal Investigator:
          • Peter Rullan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteers, of either sex, aged at least 18 years.
  • Volunteers must be capable of understanding and following directions in English.
  • Subjects who are healthy and have normal skin on the volar surface of the forearm.
  • Subjects willing and able to comply with the requirements of the study.
  • Subjects willing and able to comply with the follow-up requirements.
  • Subjects willing and able to give written and verbal informed consent.

Exclusion Criteria:

  • Subjects who are pregnant, nursing or intend to become pregnant.
  • Current treatment by a physician for allergy, unless physician consulted by Investigator and participation was approved.
  • Participation in a repeat insult patch test (RIPT), skin prick test (SPT) or follow-up work within the last month.
  • Recent immunization, including COVID-19 (less than 14 days prior to skin test).
  • Subjects who have had any form of collagen soft tissue treatment within the last 12 months.
  • Subjects with medical history indicating atopy or dermatographia ('skin writing').
  • Subject has a current skin disease of any type apart from mild facial acne (e.g., eczema, psoriasis).
  • Subject has any skin pathology or condition that could interfere with the evaluation of the treatment areas.
  • Subjects who were or are currently being treated with any systemic immuno-suppressive therapy, including but not limited to chemotherapy agents or cortico-steroids (including inhaled or insufflated) within the past 3 months.
  • Subjects who were or are currently being treated with any topical OTC drug or prescription therapy on their arms (below the elbow) within the past 3 months.
  • Subjects with a history indicative of abnormal immune function (e.g., auto- immune diseases, HIV, cancer, etc.).
  • Subjects with known lidocaine hypersensitivity.
  • Subjects with known sensitivity to bovine collagen.
  • Subjects who have a history of dietary beef allergy, undergoing desensitization to beef products or planning to undergo desensitization within the study evaluation period.
  • Subjects with severe allergies manifested by a history of anaphylaxis.
  • Subject is currently enrolled in an investigational drug or device study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Bovine Atelocollagen Skin Sensitization Test
Volunteer cohort tested for hypersensitivity towards intradermal injection of bovine atelocollagen.
Device: Bovine atelocollagen intradermal injection
Intradermal skin test injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypersensitivity Evaluation
Time Frame: 44 days

Subjects will monitor the implant sites daily for signs of local reactions and are instructed to record other clinical symptoms occurring during the course of the study. Unscheduled visits will be secured if subjects report adverse events between scheduled visits. Hypersensitivity to the xenogenic collagen test material will be assessed through visual scoring by trained clinical staff, a qualified physician, and subject diary observations. All potential reactions will be photographed by study staff for scoring confirmation.

Hypersensitivity reaction will be assessed based on FDA's recent draft guidance "Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs. A positive response is defined as a skin response greater than Score 2 of 4 mm diameter at the implant site persisting more than 72 hours, with photograph, and verification of an immune reaction by histopathology of the site biopsy.
44 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AscentX Medical, Inc.

Investigators

  • Principal Investigator: Peter Rullan, MD, Dermatology Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 25, 2022

Primary Completion (ANTICIPATED)

July 1, 2022

Study Completion (ANTICIPATED)

August 1, 2022

Study Registration Dates

First Submitted

January 27, 2022

First Submitted That Met QC Criteria

February 8, 2022

First Posted (ACTUAL)

February 10, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2022

Last Update Submitted That Met QC Criteria

February 8, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 21-ASMI-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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