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Combined LASERs and PRP for Postacne Scars

Primary Purpose

Atrophic Acne Scar

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Lasers
Platelets Rich Plasma
Lasers plus Normal Saline Solution
Sponsored by
DEKA S.r.l.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrophic Acne Scar focused on measuring Acne scars, fractional lasers, PRP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients with atrophic post-acne scars.
  2. Patients without surgical &/or LASER resurfacing treatment for acne scars within the last 6 months.

Exclusion Criteria:

  1. Pregnancy
  2. Present or past history of hypertrophic scars or keloids
  3. Present or past history of photosensitivity dermatoses including Connective Tissue Diseases.
  4. Present history of herpes infection
  5. Present history of Anemia (HGB < 10 g/dl), Thrombocytopenia &/or Platelets dysfunction.
  6. Patients receiving isotretinoin within the last 3 months, NSAIDs within 72 hours of the procedure, anticoagulants &/or systemic use of corticosteroids within 2 weeks.

Sites / Locations

  • DEKA M.E.L.A. S.r.l.
  • Cosmetic Surgery Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Sham Comparator

Active Comparator

Arm Label

Control

Lasers plus Normal Saline Solution

Lasers plus Platelets Rich Plasma (PRP)

Arm Description

32 biopsy specimens from acne scars will be excised without any treatment.

32 biopsy specimens will be excised immediately after being treated with lasers and subsequent injection of normal saline solution.

32 biopsy specimens will be excised immediately after being treated with lasers and subsequent injection of platelets Rich Plasma (PRP).

Outcomes

Primary Outcome Measures

Change in Patients' response denoting early Clinical improvement
calculating the change in 17 questions' responses of a new Patient Oriented Tool questionnaire for assessing Atrophic Acne Scarring through two parts; a) assessment of Acne Scar Appearance and b) Acne Scar Quality of Life questionnaire. Patients will record their responses before the 1st session and on the date of 2nd session.
Final Clinical improvement assessed using (0-10) scoring scale by blind assessors
The change in scores comparing 2 sets of digital photographs for each patient evaluated by 3 blind assessors, before and after 12 weeks of the 4th session. This blind assessment score will be compared to patients' score in their previous questionnaire.

Secondary Outcome Measures

Higher new collagen formation in scars treated using lasers plus PRP technique
Picrosirus Red stained specimens under circularly polarized microscopy will be segmented into two color threshold bands (Green/Yellow G/Y and Red/Orange R/O) in the color HSB space. This will be numerically evaluated using ImageJ computer program
Immunohistochemical evaluation of Collagen I, Collagen III, and MMP-2
Using a 4 grade scale (0, +, ++, +++), the 288 slides (i.e. 3 slides prepared from 96 specimens obtained from 32 patients) will be arranged for comparison among control, sham comparator and, active comparator. Also, results will be correlated to previous numerical ImageJ computerized assessment and patients' clinical improvement.

Full Information

First Posted
January 14, 2019
Last Updated
November 26, 2019
Sponsor
DEKA S.r.l.
Collaborators
Universitat Autonoma de Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT03809416
Brief Title
Combined LASERs and PRP for Postacne Scars
Official Title
Combined Fractional LASERs Resurfacing With Platelets Rich Plasma (PRP) for Treating Post Acne Atrophic Scarring
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DEKA S.r.l.
Collaborators
Universitat Autonoma de Barcelona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study evaluates a new combined technique using two different laser wavelengths and Platelets Rich Plasma (PRP) to treat post-atrophic acne scars. Within the available knowledge of laser-tissue interactions and effects of PRP on wound healing, we will explore the clinical effects of our new combination procedure on a histopathological and immunohistochemical basis for guiding future post acne scars clinical research.
Detailed Description
The carbon dioxide and erbium lasers have been the gold and silver standards for acne scars treatment. As with selective photothermolysis, a major advance in the field is the incorporation of grids of MicroThermal Zones (MTZ) that spares islands of skin with an attractive treatment efficacy to downtime healing (5-7 days) ratio. Application of these fractionated resurfacing to carbon dioxide and erbium lasers allows deeper penetration into the skin. Fractional photothermolysis was first described by as a new method for delivery of laser energy with the potential of laser safety and efficacy. Through the delivery of microscopic, non-contagious zones of thermal damage using a 1550 nm, mid-infra-red laser source, it was observed that surrounding islands of dermal and epidermal cells facilitated post-treatment collagen remodeling and rapid healing. Despite the success of minimally ablative and fractional technologies, there remained a need for more aggressive tissue ablation for the purposes of tissue rejuvenation of severely photodamaged skin and deeper rhytides. This might be due to the variability of architecture, depth, and width; thus, each type of scar has an optimal method by which it can be improved. The idea of combining both carbon dioxide and erbium lasers appeared even before the era of fractional lasers. McDaniel et al, combined both non-fractional lasers for resurfacing of perioral rhytides comparing it to using carbon dioxide lasers alone and concluded that carbon dioxide laser resurfacing followed by 3 passes of erbium laser reduces the duration of crusting, swelling and itching when compared to carbon dioxide laser resurfacing alone with no significant difference in the outcome. Later in 2010, the combination of fractional lasers carbon dioxide and erbium-doped laser was tried out for treating mild acne scars by a group of researchers. They reported a longer post laser erythema and hyperpigmentation, without precise pathogenesis. However, they suggested that these unexpected outcomes may have resulted from bulk heat damage to the surrounding tissues by heat stacking and recommended further studies to determine the optimal treatment parameters and reduce unexpected adverse reactions. Platelet-rich plasma (PRP) is a high concentration of platelets in a small volume of plasma. PRP contains various growth factors and cytokines released by platelets, and those substances play a critical role in all aspects of the wound healing process. Among the stored mitogenic factors essential for wound repair are platelet-derived growth factor (PDGF) with the -AB and -C isoforms predominating, transforming growth factor β (TGF-β), vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF), platelet-derived epidermal growth factor (PDEGF) and insulin-like growth factor-1 (IGF-1). These are variously involved in stimulating chemotaxis, cell proliferation, and maturation. PDGF is a powerful chemoattractant and stimulator of cell proliferation. All of them are potent angiogenic factors and endothelial cell mitogens. The wound healing effect of PRP is relatively well known, and PRP has been used in bone surgery, tendon and ligament repair, and chronic leg ulcer treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophic Acne Scar
Keywords
Acne scars, fractional lasers, PRP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
32 biopsy specimens from acne scars will be excised without any treatment.
Arm Title
Lasers plus Normal Saline Solution
Arm Type
Sham Comparator
Arm Description
32 biopsy specimens will be excised immediately after being treated with lasers and subsequent injection of normal saline solution.
Arm Title
Lasers plus Platelets Rich Plasma (PRP)
Arm Type
Active Comparator
Arm Description
32 biopsy specimens will be excised immediately after being treated with lasers and subsequent injection of platelets Rich Plasma (PRP).
Intervention Type
Device
Intervention Name(s)
Lasers
Other Intervention Name(s)
Fractional CO2 and Erbium Glass Lasers
Intervention Description
Fractional carbon dioxide laser will be applied only over spots of deep post-acne scars, while Erbium: Glass will be applied all over face except to the two predetermined spots, i.e. control and another spot where NSS will be injected.
Intervention Type
Other
Intervention Name(s)
Platelets Rich Plasma
Other Intervention Name(s)
PRP
Intervention Description
Platelet Rich Plasma (PRP) will be prepared from autologous blood collection in a syringe prefilled with anticoagulant solution followed by centrifugation then adding calcium gluconate 10% for induction of platelet activation. Activated PRP will be injected for all carbon dioxide laser spots in each patient immediately after each laser session except for two predetermined spots, i.e. control and sham comparator, which will be injected by normal saline solution (NSS).
Intervention Type
Combination Product
Intervention Name(s)
Lasers plus Normal Saline Solution
Other Intervention Name(s)
NSS
Intervention Description
Normal Saline Solution will be injected only in one spot after combined lasers resufacing to act as sham comparator compared to the other spot of Lasers plus PRP injection
Primary Outcome Measure Information:
Title
Change in Patients' response denoting early Clinical improvement
Description
calculating the change in 17 questions' responses of a new Patient Oriented Tool questionnaire for assessing Atrophic Acne Scarring through two parts; a) assessment of Acne Scar Appearance and b) Acne Scar Quality of Life questionnaire. Patients will record their responses before the 1st session and on the date of 2nd session.
Time Frame
4 weeks after the 1st session
Title
Final Clinical improvement assessed using (0-10) scoring scale by blind assessors
Description
The change in scores comparing 2 sets of digital photographs for each patient evaluated by 3 blind assessors, before and after 12 weeks of the 4th session. This blind assessment score will be compared to patients' score in their previous questionnaire.
Time Frame
12 weeks after the 4th session
Secondary Outcome Measure Information:
Title
Higher new collagen formation in scars treated using lasers plus PRP technique
Description
Picrosirus Red stained specimens under circularly polarized microscopy will be segmented into two color threshold bands (Green/Yellow G/Y and Red/Orange R/O) in the color HSB space. This will be numerically evaluated using ImageJ computer program
Time Frame
Immediately after the 1st session
Title
Immunohistochemical evaluation of Collagen I, Collagen III, and MMP-2
Description
Using a 4 grade scale (0, +, ++, +++), the 288 slides (i.e. 3 slides prepared from 96 specimens obtained from 32 patients) will be arranged for comparison among control, sham comparator and, active comparator. Also, results will be correlated to previous numerical ImageJ computerized assessment and patients' clinical improvement.
Time Frame
Immediately after the 1st session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with atrophic post-acne scars. Patients without surgical &/or LASER resurfacing treatment for acne scars within the last 6 months. Exclusion Criteria: Pregnancy Present or past history of hypertrophic scars or keloids Present or past history of photosensitivity dermatoses including Connective Tissue Diseases. Present history of herpes infection Present history of Anemia (HGB < 10 g/dl), Thrombocytopenia &/or Platelets dysfunction. Patients receiving isotretinoin within the last 3 months, NSAIDs within 72 hours of the procedure, anticoagulants &/or systemic use of corticosteroids within 2 weeks.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lluis Puig, MD, PhD
Organizational Affiliation
Universitat Autonoma de Barcelona (UAB)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alberto Calligaro, MD, PhD
Organizational Affiliation
University of Pavia
Official's Role
Principal Investigator
Facility Information:
Facility Name
DEKA M.E.L.A. S.r.l.
City
Firenze
State/Province
Calenzano
ZIP/Postal Code
50041
Country
Italy
Facility Name
Cosmetic Surgery Clinic
City
Al Qādisīyah
ZIP/Postal Code
35858
Country
Kuwait

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27008237
Citation
Layton A, Dreno B, Finlay AY, Thiboutot D, Kang S, Lozada VT, Bourdes V, Bettoli V, Petit L, Tan J. Erratum to: New Patient-Oriented Tools for Assessing Atrophic Acne Scarring. Dermatol Ther (Heidelb). 2016 Jun;6(2):235-6. doi: 10.1007/s13555-016-0107-8. No abstract available.
Results Reference
result
PubMed Identifier
15216537
Citation
Manstein D, Herron GS, Sink RK, Tanner H, Anderson RR. Fractional photothermolysis: a new concept for cutaneous remodeling using microscopic patterns of thermal injury. Lasers Surg Med. 2004;34(5):426-38. doi: 10.1002/lsm.20048.
Results Reference
result
PubMed Identifier
19603309
Citation
Cho SB, Lee SJ, Kang JM, Kim YK, Oh SH. Combined fractional laser treatment with 1550-nm erbium glass and 10 600-nm carbon dioxide lasers. J Dermatolog Treat. 2010 Jul;21(4):221-8. doi: 10.1080/09546630903089650. No abstract available.
Results Reference
result
PubMed Identifier
21635618
Citation
Lee JW, Kim BJ, Kim MN, Mun SK. The efficacy of autologous platelet rich plasma combined with ablative carbon dioxide fractional resurfacing for acne scars: a simultaneous split-face trial. Dermatol Surg. 2011 Jul;37(7):931-8. doi: 10.1111/j.1524-4725.2011.01999.x. Epub 2011 Jun 2.
Results Reference
result
PubMed Identifier
19891690
Citation
Prignano F, Campolmi P, Bonan P, Ricceri F, Cannarozzo G, Troiano M, Lotti T. Fractional CO2 laser: a novel therapeutic device upon photobiomodulation of tissue remodeling and cytokine pathway of tissue repair. Dermatol Ther. 2009 Nov;22 Suppl 1:S8-15. doi: 10.1111/j.1529-8019.2009.01265.x.
Results Reference
result

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Combined LASERs and PRP for Postacne Scars

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