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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
Shin Kong Wu Ho-Su Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

First Posted
April 1, 2021
Last Updated
April 1, 2021
Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
Collaborators
Spirit Scientific
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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:
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Citation
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Clinical Application of Patented Lyophilized PLT in Acne Scar Repairment.

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