Clinical Application of Patented Lyophilized PLT in Acne Scar Repairment.

NCT04829370 | Completed

• 1 other identifier: 20170903R
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrophic Acne Scar

Keywords

Platelet; PLT; Growth factor; Acne scar repairment; Laser

Outcome Measures

Primary Outcomes (1)

• adverse effect assessment

  adverse effect assessment, Safety

  20 weeks

Secondary Outcomes (2)

• Global assessment of acne scar

  20 weeks

• wound healing rate

  20 weeks

Study Arms (2)

PLT

ACTIVE COMPARATOR

All subjects are treated with fractional carbon dioxide laser, then applied 2 mL PLT solution (dissolved in normal saline) on the right face.

Other: PLT

Saline

PLACEBO COMPARATOR

All subjects are treated with fractional carbon dioxide laser, the left face (control group) be applied 2 mL normal saline

Other: Saline

Interventions

PLT OTHER

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.

PLT

Saline OTHER

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.

Saline

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• Shin Kong Wu Ho-Su Memorial Hospital: lead
• Spirit Scientific: collaborator

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

Location

Related Publications (23)

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  PMID: 19282841 BACKGROUND

• 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.

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  PMID: 11705090 BACKGROUND

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  PMID: 27189872 BACKGROUND

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  PMID: 29344322 BACKGROUND

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  PMID: 19065083 BACKGROUND

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• 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.

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• 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.

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MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Chieh-Chen Huang, Shin Kong Wu Ho Su Memorial, M

  Department of Dermatology, Shin Kong Wu Ho Su Memorial Hospital,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, single-blind, parallel study at a single health care center.

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 2, 2021
• Study Start: March 20, 2020
• Primary Completion: September 28, 2020
• Study Completion: October 30, 2020
• Last Updated: April 2, 2021

Record last verified: 2021-03

Locations

TW (1)