Clinical Application of Patented Lyophilized PLT in Acne Scar Repairment.

Atrophic Acne Scar Clinical Trial

Official title:

Clinical Application of Patented Lyophilized PLT in Acne Scar Repairment.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04829370
• Other study ID #: 20170903R
• Status: Completed
• Phase: N/A
• Start date: March 20, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: March 2021
• Source: Shin Kong Wu Ho-Su Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

All kinds of skin problems will cause a person's life caused by varying degrees of trouble, especially issues at face. No matter diseases or aging would cause mental pressure and the inconvenience in different ages.

Scar caused by acne is the most common skin issue amount young people. While acne recovering, due to the destruction of collagen forming fibrous tissue, and scars be left. Clinical treatments are facial laser, argon laser and carbon dioxide laser. With the combination of rejuvenation to accelerate growth of collagen when needed. According to journal articles, facial laser combined with Platelet-rich plasma is more curative than facial laser treatment alone and can significantly reduce side effects (Dermatol Surg. 2014 Feb;40(2):152-61).

Platelet has been valued in regeneration medicine due to its various growth factors with repairment, induction and promotion functions. Moreover, low risk of allergy for it is an autologous material. Platelet had been officially applied in orthopedics and more clinical studies in many other fields. Nowadays, preparation of PRP is by single-use centrifuge tube, patients have to go through blood collection process every time before therapy due to short shelf life of PRP. Meanwhile, amount of platelet in PRP would be different due to difference of individual, health condition and separation methods. Thus, leaving unknown of active principle and uncertainty of treatments.

In this trial, a patented technique of lyophilized PLT preparation method is applied, collect 250 c.c. of blood specimen by using blood bag, separate platelet in germ-free clean room, then lyophilize platelet to extend shelf life to at least three years after quantifying platelet amount. Therefore, treatment could be done after simple dissolution process of PLT leads to the convenience of multiple therapy lessons.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 30, 2020
• Est. primary completion date: September 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• all subjects of acne scars are defined of grades 1, 2, and 3 [Goodman and Baron Grading scale] were enrolled in the study.

Exclusion Criteria:

• Exclusion criteria included treatment with any laser device treatment to the face within 1 month, use of systemic retinoids within 3 months, pregnancy or lactation, a history of hypertrophic scarring or keloids, cancer therapies, uncontrolled diabetes, chronic liver or kidney disease, cardiovascular disease or hematologic disorders. Subjects were requested to avoid using any topical products containing alpha-hydroxy acids and salicylic acid on the face during the study period.

Related Conditions & MeSH terms

• Acne Vulgaris
• Atrophic Acne Scar

Intervention

Other:
• PLT
The study will be conducted by using a fractional carbon dioxide laser for acne scar treatment. After the treatment, each patient enrolled will be applied 2 mL PLT solution on the right face. Treatment mentioned above will be repeated every 3 to 4 weeks, overall 4 times treatment and one month follow up after fourth treatment. Every record will be documented in questionnaires by the principal investigator and the patient itself. Moreover, VISIA is applied for objective observation, such as spots, wrinkles, texture, pores, UV spots, brown spots, red area, and porphyrins could be objectively analyzed.
• Saline
The study will be conducted by using a fractional carbon dioxide laser for acne scar treatment. After the treatment, each patient enrolled left face be applied 2 mL normal saline. Treatment mentioned above will be repeated every 3 to 4 weeks, overall 4 times treatment and one month follow up after fourth treatment. Every record will be documented in questionnaires by the principal investigator and the patient itself. Moreover, VISIA is applied for objective observation, such as spots, wrinkles, texture, pores, UV spots, brown spots, red area, and porphyrins could be objectively analyzed.

Locations

Country	Name	City	State
Taiwan	Shin Kong Wu Ho-Su Memorial Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Shin Kong Wu Ho-Su Memorial Hospital	Spirit Scientific

Country where clinical trial is conducted

Taiwan, 

References & Publications (23)

Collier CN, Harper JC, Cafardi JA, Cantrell WC, Wang W, Foster KW, Elewski BE. The prevalence of acne in adults 20 years and older. J Am Acad Dermatol. 2008 Jan;58(1):56-9. Epub 2007 Oct 22. Erratum in: J Am Acad Dermatol. 2008 May;58(5):874. Cafardi, Jennifer A [added]. — View Citation

Connolly D, Vu HL, Mariwalla K, Saedi N. Acne Scarring-Pathogenesis, Evaluation, and Treatment Options. J Clin Aesthet Dermatol. 2017 Sep;10(9):12-23. Epub 2017 Sep 1. Review. — View Citation

Dougherty EJ. An evidence-based model comparing the cost-effectiveness of platelet-rich plasma gel to alternative therapies for patients with nonhealing diabetic foot ulcers. Adv Skin Wound Care. 2008 Dec;21(12):568-75. doi: 10.1097/01.ASW.0000323589.27605.71. — View Citation

Dunn LK, O'Neill JL, Feldman SR. Acne in adolescents: quality of life, self-esteem, mood, and psychological disorders. Dermatol Online J. 2011 Jan 15;17(1):1. Review. — View Citation

Fabbrocini G, Annunziata MC, D'Arco V, De Vita V, Lodi G, Mauriello MC, Pastore F, Monfrecola G. Acne scars: pathogenesis, classification and treatment. Dermatol Res Pract. 2010;2010:893080. doi: 10.1155/2010/893080. Epub 2010 Oct 14. — View Citation

Gawdat HI, Hegazy RA, Fawzy MM, Fathy M. Autologous platelet rich plasma: topical versus intradermal after fractional ablative carbon dioxide laser treatment of atrophic acne scars. Dermatol Surg. 2014 Feb;40(2):152-61. doi: 10.1111/dsu.12392. Epub 2013 Dec 19. Erratum in: Dermatol Surg. 2014 May;40(5):601. — View Citation

Ghodsi SZ, Orawa H, Zouboulis CC. Prevalence, severity, and severity risk factors of acne in high school pupils: a community-based study. J Invest Dermatol. 2009 Sep;129(9):2136-41. doi: 10.1038/jid.2009.47. Epub 2009 Mar 12. — View Citation

Goodman GJ, Baron JA. Postacne scarring--a quantitative global scarring grading system. J Cosmet Dermatol. 2006 Mar;5(1):48-52. — View Citation

Hom DB, Linzie BM, Huang TC. The healing effects of autologous platelet gel on acute human skin wounds. Arch Facial Plast Surg. 2007 May-Jun;9(3):174-83. — View Citation

Hui Q, Chang P, Guo B, Zhang Y, Tao K. The Clinical Efficacy of Autologous Platelet-Rich Plasma Combined with Ultra-Pulsed Fractional CO(2) Laser Therapy for Facial Rejuvenation. Rejuvenation Res. 2017 Feb;20(1):25-31. doi: 10.1089/rej.2016.1823. Epub 2016 Jun 23. — View Citation

Jee CH, Eom NY, Jang HM, Jung HW, Choi ES, Won JH, Hong IH, Kang BT, Jeong DW, Jung DI. Effect of autologous platelet-rich plasma application on cutaneous wound healing in dogs. J Vet Sci. 2016 Mar;17(1):79-87. doi: 10.4142/jvs.2016.17.1.79. Epub 2016 Mar 22. — View Citation

Kieb M, Sander F, Prinz C, Adam S, Mau-Möller A, Bader R, Peters K, Tischer T. Platelet-Rich Plasma Powder: A New Preparation Method for the Standardization of Growth Factor Concentrations. Am J Sports Med. 2017 Mar;45(4):954-960. doi: 10.1177/0363546516674475. Epub 2016 Dec 13. — View Citation

Layton AM. Optimal management of acne to prevent scarring and psychological sequelae. Am J Clin Dermatol. 2001;2(3):135-41. Review. — View Citation

Leo MS, Kumar AS, Kirit R, Konathan R, Sivamani RK. Systematic review of the use of platelet-rich plasma in aesthetic dermatology. J Cosmet Dermatol. 2015 Dec;14(4):315-23. doi: 10.1111/jocd.12167. Epub 2015 Jul 23. Review. — View Citation

Manuskiatti W, Triwongwaranat D, Varothai S, Eimpunth S, Wanitphakdeedecha R. Efficacy and safety of a carbon-dioxide ablative fractional resurfacing device for treatment of atrophic acne scars in Asians. J Am Acad Dermatol. 2010 Aug;63(2):274-83. doi: 10.1016/j.jaad.2009.08.051. — View Citation

Moradi Tuchayi S, Makrantonaki E, Ganceviciene R, Dessinioti C, Feldman SR, Zouboulis CC. Acne vulgaris. Nat Rev Dis Primers. 2015 Sep 17;1:15029. doi: 10.1038/nrdp.2015.29. Review. — View Citation

Na JI, Choi JW, Choi HR, Jeong JB, Park KC, Youn SW, Huh CH. Rapid healing and reduced erythema after ablative fractional carbon dioxide laser resurfacing combined with the application of autologous platelet-rich plasma. Dermatol Surg. 2011 Apr;37(4):463-8. doi: 10.1111/j.1524-4725.2011.01916.x. — View Citation

Ong MW, Bashir SJ. Fractional laser resurfacing for acne scars: a review. Br J Dermatol. 2012 Jun;166(6):1160-9. doi: 10.1111/j.1365-2133.2012.10870.x. Epub 2012 May 8. Review. — View Citation

Sánchez Viera M. Management of acne scars: fulfilling our duty of care for patients. Br J Dermatol. 2015 Jul;172 Suppl 1:47-51. doi: 10.1111/bjd.13650. Review. — View Citation

Sclafani AP, Romo T 3rd, Ukrainsky G, McCormick SA, Litner J, Kevy SV, Jacobson MS. Modulation of wound response and soft tissue ingrowth in synthetic and allogeneic implants with platelet concentrate. Arch Facial Plast Surg. 2005 May-Jun;7(3):163-9. — View Citation

Shin MK, Lee JH, Lee SJ, Kim NI. Platelet-rich plasma combined with fractional laser therapy for skin rejuvenation. Dermatol Surg. 2012 Apr;38(4):623-30. doi: 10.1111/j.1524-4725.2011.02280.x. Epub 2012 Jan 30. — View Citation

Tambella AM, Attili AR, Dupré G, Cantalamessa A, Martin S, Cuteri V, Marcazzan S, Del Fabbro M. Platelet-rich plasma to treat experimentally-induced skin wounds in animals: A systematic review and meta-analysis. PLoS One. 2018 Jan 11;13(1):e0191093. doi: 10.1371/journal.pone.0191093. eCollection 2018. Review. — View Citation

Zhu JT, Xuan M, Zhang YN, Liu HW, Cai JH, Wu YH, Xiang XF, Shan GQ, Cheng B. The efficacy of autologous platelet-rich plasma combined with erbium fractional laser therapy for facial acne scars or acne. Mol Med Rep. 2013 Jul;8(1):233-7. doi: 10.3892/mmr.2013.1455. Epub 2013 May 2. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adverse effect assessment	adverse effect assessment, Safety	20 weeks
Secondary	Global assessment of acne scar	5-point grading of acne scar	20 weeks
Secondary	wound healing rate	7-days grading of wound healing	20 weeks