Atrophic Acne ScarNCT04829370
Clinical Application of Patented Lyophilized PLT in Acne Scar Repairment.
A study testing PLT and Saline in people with Atrophic Acne Scar, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrophic Acne Scar
- What is being tested?
- PLT and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Mar 2020to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- all subjects of acne scars are defined of grades 1, 2, and 3 [Goodman and Baron Grading scale] were enrolled in the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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
- Being tested
- PLT, Saline
- Keywords
- Platelet, PLT, Growth factor, Acne scar repairment, Laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLTOther
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.
SalineOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse effect assessment
adverse effect assessment, Safety
Measured: 20 weeks
Secondary outcomes (2)
Global assessment of acne scar
5-point grading of acne scar
Measured: 20 weeks
wound healing rate
7-days grading of wound healing
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start20 Mar 2020
- Primary completion28 Sep 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Atrophic Acne ScarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- A prospective, single-blind, parallel study at a single health care center.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Spirit Scientific
- Responsible party
- Sponsor
- Investigators
- Chieh-Chen Huang, Shin Kong Wu Ho Su Memorial, M, Principal investigator, Department of Dermatology, Shin Kong Wu Ho Su Memorial Hospital,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829370
- Sponsor's protocol ID
- 20170903R
- Status last verified
- Mar 2021
- First submitted
- 1 Apr 2021
- Last updated
- 2 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 19282841Collier 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.
PubMed 17945383Layton 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.
PubMed 11705090Moradi 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.
PubMed 27189872Connolly 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.
PubMed 29344322Fabbrocini 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.
PubMed 20981308Dunn 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.
PubMed 21272492Sanchez 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.
PubMed 25597636Ong 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.
PubMed 22296284Manuskiatti 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.
PubMed 20633798Sclafani 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.
PubMed 15897404Hom 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.
PubMed 17519207Dougherty 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.
PubMed 19065083Jee 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.
PubMed 27051343Tambella 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.
PubMed 29324848
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of Patented Lyophilized PLT in Acne Scar Repairment.
- ClinicalTrials.gov ID
- NCT04829370
- Acronym / sponsor ID
- 20170903R
- Conditions
- Atrophic Acne Scar
- Keywords
- Platelet, PLT, Growth factor, Acne scar repairment, Laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Collaborators
- Spirit Scientific
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 28 Sep 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 2 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A prospective, single-blind, parallel study at a single health care center.
| Arm | Type | Receives |
|---|---|---|
| PLT | Active comparator | Other: PLTAll subjects are treated with fractional carbon dioxide laser, then applied 2 mL PLT solution (dissolved in normal saline) on the right face. |
| Saline | Placebo comparator | Other: SalineAll subjects are treated with fractional carbon dioxide laser, the left face (control group) be applied 2 mL normal saline |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all subjects of acne scars are defined of grades 1, 2, and 3 [Goodman and Baron Grading scale] were enrolled in the study.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLTThe 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. | Other | PLT |
| SalineThe 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. | Other | Saline |
Primary outcome
adverse effect assessment
Time frame: 20 weeks
adverse effect assessment, Safety
2 secondary outcomes
Global assessment of acne scar
Time frame: 20 weeks
wound healing rate
Time frame: 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
- Background: PubMed 19282841Ghodsi 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.
- Background: PubMed 17945383Collier 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.
- Background: PubMed 11705090Layton 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.
- Background: PubMed 27189872Moradi 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.
- Background: PubMed 29344322Connolly 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.
- Background: PubMed 20981308Fabbrocini 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.
- Background: PubMed 21272492Dunn 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.
- Background: PubMed 25597636Sanchez 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.
- Background: PubMed 22296284Ong 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.
- Background: PubMed 20633798Manuskiatti 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.
- Background: PubMed 15897404Sclafani 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.
- Background: PubMed 17519207Hom 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chieh-Chen Huang, Shin Kong Wu Ho Su Memorial, M principal investigator
Department of Dermatology, Shin Kong Wu Ho Su Memorial Hospital,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PLT and Saline in people with Atrophic Acne Scar, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse effect assessment (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04829370, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2021.