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Combined LASERs and PRP for Postacne Scars

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ClinicalTrials.gov Identifier: NCT03809416
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : January 23, 2019
Sponsor:
Collaborator:
Universitat Autonoma de Barcelona
Information provided by (Responsible Party):
DEKA S.r.l.

Tracking Information
First Submitted Date  ICMJE January 14, 2019
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date January 23, 2019
Actual Study Start Date  ICMJE October 1, 2018
Estimated Primary Completion Date March 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2019)
  • Change in Patients' response denoting early Clinical improvement [ Time Frame: 4 weeks after the 1st session ]
    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 [ Time Frame: 12 weeks after the 4th session ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03809416 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2019)
  • Higher new collagen formation in scars treated using lasers plus PRP technique [ Time Frame: Immediately after the 1st session ]
    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 [ Time Frame: Immediately after the 1st session ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combined LASERs and PRP for Postacne Scars
Official Title  ICMJE Combined Fractional LASERs Resurfacing With Platelets Rich Plasma (PRP) for Treating Post Acne Atrophic Scarring
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Atrophic Acne Scar
Intervention  ICMJE
  • Device: Lasers
    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.
    Other Name: Fractional CO2 and Erbium Glass Lasers
  • Other: Platelets Rich Plasma
    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).
    Other Name: PRP
  • Combination Product: Lasers plus Normal Saline Solution
    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
    Other Name: NSS
Study Arms  ICMJE
  • No Intervention: Control
    32 biopsy specimens from acne scars will be excised without any treatment.
  • Sham Comparator: Lasers plus Normal Saline Solution
    32 biopsy specimens will be excised immediately after being treated with lasers and subsequent injection of normal saline solution.
    Interventions:
    • Device: Lasers
    • Combination Product: Lasers plus Normal Saline Solution
  • Active Comparator: Lasers plus Platelets Rich Plasma (PRP)
    32 biopsy specimens will be excised immediately after being treated with lasers and subsequent injection of platelets Rich Plasma (PRP).
    Interventions:
    • Device: Lasers
    • Other: Platelets Rich Plasma
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 15, 2019)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2019
Estimated Primary Completion Date March 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 Inflammatory Acne lesions &/or 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Ahmed A Youssef, MD 0034677091783 drahmed.derma@gmail.com
Contact: Paolo Bonan, MD 0039666439882 pbonan@esld.eu
Listed Location Countries  ICMJE Italy,   Kuwait
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03809416
Other Study ID Numbers  ICMJE AY001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party DEKA S.r.l.
Study Sponsor  ICMJE DEKA S.r.l.
Collaborators  ICMJE Universitat Autonoma de Barcelona
Investigators  ICMJE
Study Director: Lluis Puig, MD, PhD Universitat Autonoma de Barcelona (UAB)
Principal Investigator: Alberto Calligaro, MD, PhD University of Pavia
PRS Account DEKA S.r.l.
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP