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Clinical Application of Patented Lyophilized PLT in Acne Scar Repairment.

Clinical Application of Patented Lyophilized PLT in Acne Scar Repairment.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04829370
Enrollment
15
Registered
2021-04-02
Start date
2020-03-20
Completion date
2020-10-30
Last updated
2021-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrophic Acne Scar

Keywords

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

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.

Interventions

OTHERPLT

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.

OTHERSaline

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.

Sponsors

Spirit Scientific
CollaboratorUNKNOWN
Shin Kong Wu Ho-Su Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
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

*

Design outcomes

Primary

MeasureTime frameDescription
adverse effect assessment20 weeksadverse effect assessment, Safety

Secondary

MeasureTime frameDescription
Global assessment of acne scar20 weeks5-point grading of acne scar
wound healing rate20 weeks7-days grading of wound healing

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026