Clinical Application of Patented Lyophilized PLT in Acne Scar Repairment.
Primary Purpose
Atrophic Acne Scar
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
PLT
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Atrophic Acne Scar focused on measuring Platelet, PLT, Growth factor, Acne scar repairment, Laser
Eligibility Criteria
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.
Sites / Locations
- Shin Kong Wu Ho-Su Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
PLT
Saline
Arm Description
All subjects are treated with fractional carbon dioxide laser, then applied 2 mL PLT solution (dissolved in normal saline) on the right face.
All subjects are treated with fractional carbon dioxide laser, the left face (control group) be applied 2 mL normal saline
Outcomes
Primary Outcome Measures
adverse effect assessment
adverse effect assessment, Safety
Secondary Outcome Measures
Global assessment of acne scar
5-point grading of acne scar
wound healing rate
7-days grading of wound healing
Full Information
NCT ID
NCT04829370
First Posted
April 1, 2021
Last Updated
April 1, 2021
Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
Collaborators
Spirit Scientific
1. Study Identification
Unique Protocol Identification Number
NCT04829370
Brief Title
Clinical Application of Patented Lyophilized PLT in Acne Scar Repairment.
Official Title
Clinical Application of Patented Lyophilized PLT in Acne Scar Repairment.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 20, 2020 (Actual)
Primary Completion Date
September 28, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
Collaborators
Spirit Scientific
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophic Acne Scar
Keywords
Platelet, PLT, Growth factor, Acne scar repairment, Laser
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A prospective, single-blind, parallel study at a single health care center.
Masking
Participant
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PLT
Arm Type
Active Comparator
Arm Description
All subjects are treated with fractional carbon dioxide laser, then applied 2 mL PLT solution (dissolved in normal saline) on the right face.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
All subjects are treated with fractional carbon dioxide laser, the left face (control group) be applied 2 mL normal saline
Intervention Type
Other
Intervention Name(s)
PLT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
adverse effect assessment
Description
adverse effect assessment, Safety
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Global assessment of acne scar
Description
5-point grading of acne scar
Time Frame
20 weeks
Title
wound healing rate
Description
7-days grading of wound healing
Time Frame
20 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chieh-Chen Huang, Shin Kong Wu Ho Su Memorial, M
Organizational Affiliation
Department of Dermatology, Shin Kong Wu Ho Su Memorial Hospital,
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shin Kong Wu Ho-Su Memorial Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
19282841
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.
Results Reference
background
PubMed Identifier
17945383
Citation
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. doi: 10.1016/j.jaad.2007.06.045. Epub 2007 Oct 22. Erratum In: J Am Acad Dermatol. 2008 May;58(5):874. Cafardi, Jennifer A [added].
Results Reference
background
PubMed Identifier
11705090
Citation
Layton AM. Optimal management of acne to prevent scarring and psychological sequelae. Am J Clin Dermatol. 2001;2(3):135-41. doi: 10.2165/00128071-200102030-00002.
Results Reference
background
PubMed Identifier
27189872
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.
Results Reference
background
PubMed Identifier
29344322
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.
Results Reference
background
PubMed Identifier
20981308
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.
Results Reference
background
PubMed Identifier
21272492
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.
Results Reference
background
PubMed Identifier
25597636
Citation
Sanchez 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.
Results Reference
background
PubMed Identifier
22296284
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.
Results Reference
background
PubMed Identifier
20633798
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.
Results Reference
background
PubMed Identifier
15897404
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. doi: 10.1001/archfaci.7.3.163.
Results Reference
background
PubMed Identifier
17519207
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. doi: 10.1001/archfaci.9.3.174.
Results Reference
background
PubMed Identifier
19065083
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.
Results Reference
background
PubMed Identifier
27051343
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.
Results Reference
background
PubMed Identifier
29324848
Citation
Tambella AM, Attili AR, Dupre 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.
Results Reference
background
PubMed Identifier
26205133
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.
Results Reference
background
PubMed Identifier
22288389
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.
Results Reference
background
PubMed Identifier
23653117
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.
Results Reference
background
PubMed Identifier
24354616
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.
Results Reference
background
PubMed Identifier
21481064
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.
Results Reference
background
PubMed Identifier
27222038
Citation
Hui Q, Chang P, Guo B, Zhang Y, Tao K. The Clinical Efficacy of Autologous Platelet-Rich Plasma Combined with Ultra-Pulsed Fractional CO2 Laser Therapy for Facial Rejuvenation. Rejuvenation Res. 2017 Feb;20(1):25-31. doi: 10.1089/rej.2016.1823. Epub 2016 Jun 23.
Results Reference
background
PubMed Identifier
27903591
Citation
Kieb M, Sander F, Prinz C, Adam S, Mau-Moller 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.
Results Reference
background
PubMed Identifier
17173571
Citation
Goodman GJ, Baron JA. Postacne scarring--a quantitative global scarring grading system. J Cosmet Dermatol. 2006 Mar;5(1):48-52. doi: 10.1111/j.1473-2165.2006.00222.x.
Results Reference
background
Learn more about this trial
Clinical Application of Patented Lyophilized PLT in Acne Scar Repairment.
We'll reach out to this number within 24 hrs