Bovine Atelocollagen Skin Sensitization Test

NCT05235087 | Withdrawn FDA Device

• 1 other identifier: 21-ASMI-101
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (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 Hypersensitivity reaction will be assessed based on FDA's recent draft guidance "Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs.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.

  44 days

Study Arms (1)

Bovine Atelocollagen Skin Sensitization Test

EXPERIMENTAL

Volunteer cohort tested for hypersensitivity towards intradermal injection of bovine atelocollagen.

Device: Bovine atelocollagen intradermal injection

Interventions

Bovine atelocollagen intradermal injection DEVICE

Intradermal skin test injection

Bovine Atelocollagen Skin Sensitization Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AscentX Medical, Inc.: lead

Study Sites (1)

Dermatology Institute

Chula Vista, California, 91910, United States

Location

Related Publications (11)

• 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.

  PMID: 3161303 BACKGROUND

• 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.

  PMID: 15386396 BACKGROUND

• 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.

  PMID: 33643291 BACKGROUND

• 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.

  PMID: 20376098 BACKGROUND

• 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.

  PMID: 31275329 BACKGROUND

• 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.

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 26618457 BACKGROUND

• 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.

  PMID: 15468406 BACKGROUND

Related Links

• Zyderm® highly purified dermal collagen implant
• BellaFill® Skin Test Instructions for Use (PN: 7252 Rev 00 (10/2018))
• ArteFill® FDA Summary of Safety and Effectiveness (2006)

Study Officials

• Peter Rullan, MD

  Dermatology Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 10, 2022
• Study Start: May 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)