Bovine Atelocollagen Skin Sensitization Test

Healthy Clinical Trial

Official title:

Bovine Atelocollagen Skin Sensitization Test

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05235087
• Other study ID #: 21-ASMI-101
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2022
• Est. completion date: August 2022

Study information

• Verified date: February 2022
• Source: AscentX Medical, Inc.
• Contact: Sara Adams, BA
• Phone: (619) 647-1898
• Email: sara[@]ascentxmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: August 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Bovine atelocollagen intradermal injection
Intradermal skin test injection

Locations

Country	Name	City	State
United States	Dermatology Institute	Chula Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
AscentX Medical, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

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. — View Citation

Cooperman LS, Mackinnon V, Bechler G, Pharriss BB. Injectable collagen: a six-year clinical investigation. Aesthetic Plast Surg. 1985;9(2):145-51. — View Citation

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.

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. Review. — View Citation

Pendaries V, Gasc G, Titeux M, Leroux C, Vitezica ZG, Mejía JE, Décha 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. — View Citation

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

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. — View Citation

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 a1 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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