Clinical Application of Patented Lyophilized PLT in Acne Scar Repairment.

Sponsor

Shin Kong Wu Ho-Su Memorial Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04829370

Collaborator

Spirit Scientific (Other)

Enrollment

Location

Arms

7.4

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Atrophic Acne Scar	Other: PLT Other: Saline	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Clinical Application of Patented Lyophilized PLT in Acne Scar Repairment.

Actual Study Start Date :

Mar 20, 2020

Actual Primary Completion Date :

Sep 28, 2020

Actual Study Completion Date :

Oct 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: PLT 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 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.
Placebo Comparator: Saline All subjects are treated with fractional carbon dioxide laser, the left face (control group) be applied 2 mL normal saline	Other: 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.

Arm

Intervention/Treatment

Active Comparator: PLT

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

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.

Placebo Comparator: Saline

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

Other: 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.

Outcome Measures

Primary Outcome Measures

adverse effect assessment [20 weeks]
adverse effect assessment, Safety

Secondary Outcome Measures

Global assessment of acne scar [20 weeks]
5-point grading of acne scar
wound healing rate [20 weeks]
7-days grading of wound healing

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.