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HealthyNCT05235087

Bovine Atelocollagen Skin Sensitization Test

A study testing Bovine atelocollagen intradermal injection in people with Healthy, run by AscentX Medical, Inc. at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Bovine atelocollagen skin testing of healthy adult volunteers to investigate the potential of allergy to atelocollagen medical device implants Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Bovine atelocollagen intradermal injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 May 2023to 1 Dec 2023
Phase
Interventional
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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').
Show all 16Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dermatology Institute

    Chula Vista, California, 91910

Other trials in United States

About this study

Bovine atelocollagen skin testing of healthy adult volunteers to investigate the potential of allergy to atelocollagen medical device implants

Read the 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.

Conditions
Healthy
Being tested
Bovine atelocollagen intradermal injection

What participants receive

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

  • Bovine atelocollagen intradermal injectionDevice

    Intradermal skin test injection

Study groups in NCT05235087
Study groupRoleWhat they receive
Bovine Atelocollagen Skin Sensitization TestExperimentalVolunteer cohort tested for hypersensitivity towards intradermal injection of bovine atelocollagen.
Receives: Device: Bovine atelocollagen intradermal injection

What is being measured

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

  1. Hypersensitivity Evaluation

    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.

    Measured: 44 days

Timeline

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

  1. First posted10 Feb 2022
  2. Study start1 May 2023 (estimated)
  3. Primary completion1 Nov 2023 (estimated)
  4. Study completion1 Dec 2023 (estimated)

Why it stopped: AscentX Medical's business strategy changed.

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 N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05235087
Sponsor's protocol ID
21-ASMI-101
Status last verified
Jul 2024
First submitted
27 Jan 2022
Last updated
1 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Cooperman LS, Mackinnon V, Bechler G, Pharriss BB. Injectable collagen: a six-year clinical investigation. Aesthetic Plast Surg. 1985;9(2):145-51. doi: 10.1007/BF01570347.

    PubMed 3161303

  • Lynn AK, Yannas IV, Bonfield W. Antigenicity and immunogenicity of collagen. J Biomed Mater Res B Appl Biomater. 2004 Nov 15;71(2):343-54. doi: 10.1002/jbm.b.30096.

    PubMed 15386396

  • Velosa APP, Brito L, de Jesus Queiroz ZA, Carrasco S, Tomaz de Miranda J, Farhat C, Goldenstein-Schainberg C, Parra ER, de Andrade DCO, Silva PL, Capelozzi VL, Teodoro WR. Identification of Autoimmunity to Peptides of Collagen V alpha1 Chain as Newly Biomarkers of Early Stage of Systemic Sclerosis. Front Immunol. 2021 Feb 12;11:604602. doi: 10.3389/fimmu.2020.604602. eCollection 2020.

    PubMed 33643291

  • Pendaries V, Gasc G, Titeux M, Leroux C, Vitezica ZG, Mejia JE, Decha A, Loiseau P, Bodemer C, Prost-Squarcioni C, Hovnanian A. Immune reactivity to type VII collagen: implications for gene therapy of recessive dystrophic epidermolysis bullosa. Gene Ther. 2010 Jul;17(7):930-7. doi: 10.1038/gt.2010.36. Epub 2010 Apr 8.

    PubMed 20376098

  • Ujiie H, Yoshimoto N, Natsuga K, Muramatsu K, Iwata H, Nishie W, Shimizu H. Immune Reaction to Type XVII Collagen Induces Intramolecular and Intermolecular Epitope Spreading in Experimental Bullous Pemphigoid Models. Front Immunol. 2019 Jun 19;10:1410. doi: 10.3389/fimmu.2019.01410. eCollection 2019.

    PubMed 31275329

  • Daniels, et al. Process for augmenting connective mammalian tissue with in situ polymerizable native collagen solution. US 3,949,073, United States Patent and Trademark Office, 6 April 1976.

  • Luck, et al. Aqueous collagen composition. US 4,140,537, United States Patent and Trademark Office, 20 February 1979.

  • Luck, et al. Non-antigenic collagen and articles of manufacture. US 4,233,360, United States Patent and Trademark Office, 11 November 1980.

  • Smestad, et al. Injectable cross-linked collagen implant material. US 4,582,640, United States Patent and Trademark Office, 15 April 1986

  • Cohen S, Dover J, Monheit G, Narins R, Sadick N, Werschler WP, Karnik J, Smith SR. Five-Year Safety and Satisfaction Study of PMMA-Collagen in the Correction of Nasolabial Folds. Dermatol Surg. 2015 Dec;41 Suppl 1:S302-13. doi: 10.1097/DSS.0000000000000542.

    PubMed 26618457

  • Cohen SR, Holmes RE. Artecoll: a long-lasting injectable wrinkle filler material: Report of a controlled, randomized, multicenter clinical trial of 251 subjects. Plast Reconstr Surg. 2004 Sep 15;114(4):964-76; discussion 977-9. doi: 10.1097/01.prs.0000133169.16467.5f.

    PubMed 15468406

Questions about this trial

What is this clinical trial studying?

A study testing Bovine atelocollagen intradermal injection in people with Healthy, run by AscentX Medical, Inc. at 1 site 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 6 inclusion and 16 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: withdrawn, as of the sponsor's last update on 1 Aug 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Hypersensitivity Evaluation (time frame: 44 days). 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 NCT05235087, which also lists 11 linked publications.

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 1 Aug 2024.

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