NCT03809416

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

November 29, 2019

Status Verified

November 1, 2019

Enrollment Period

9 months

First QC Date

January 14, 2019

Last Update Submit

November 26, 2019

Conditions

Atrophic Acne Scar

Keywords

Acne scarsfractional lasersPRP

Outcome Measures

Primary Outcomes (2)

  • 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.

    4 weeks after the 1st 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.

    12 weeks after the 4th session

Secondary Outcomes (2)

  • Higher new collagen formation in scars treated using lasers plus PRP technique

    Immediately after the 1st session

  • Immunohistochemical evaluation of Collagen I, Collagen III, and MMP-2

    Immediately after the 1st session

Study Arms (3)

Control

NO INTERVENTION

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

Lasers plus Normal Saline Solution

SHAM COMPARATOR

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

Device: LasersCombination Product: Lasers plus Normal Saline Solution

Lasers plus Platelets Rich Plasma (PRP)

ACTIVE COMPARATOR

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

Device: LasersOther: Platelets Rich Plasma

Interventions

LasersDEVICE

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.

Also known as: Fractional CO2 and Erbium Glass Lasers
Lasers plus Normal Saline SolutionLasers plus Platelets Rich Plasma (PRP)
Platelets Rich PlasmaOTHER

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).

Also known as: PRP
Lasers plus Platelets Rich Plasma (PRP)
Lasers plus Normal Saline SolutionCOMBINATION_PRODUCT

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

Also known as: NSS
Lasers plus Normal Saline Solution

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

DEKA M.E.L.A. S.r.l.

Florence, Calenzano, 50041, Italy

Location

Cosmetic Surgery Clinic

Al Qādisīyah, 35858, Kuwait

Location

Related Publications (5)

  • 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.

    PMID: 27008237RESULT

  • 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.

    PMID: 15216537RESULT

  • 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.

    PMID: 19603309RESULT

  • 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.

    PMID: 21635618RESULT

  • 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.

    PMID: 19891690RESULT

MeSH Terms

Interventions

Lasers

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Lluis Puig, MD, PhD

    Universitat Autonoma de Barcelona (UAB)

    STUDY DIRECTOR

  • Alberto Calligaro, MD, PhD

    University of Pavia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2019

First Posted

January 18, 2019

Study Start

October 1, 2018

Primary Completion

June 30, 2019

Study Completion

October 30, 2019

Last Updated

November 29, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

KU(1)IT(1)