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Combined LASERs and PRP for Postacne Scars

NCT03809416 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-11-29

No results posted yet for this study

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.

Conditions

  • Atrophic Acne Scar

Interventions

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

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).

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

Sponsors & Collaborators

  • Universitat Autonoma de Barcelona

    collaborator OTHER

  • DEKA S.r.l.

    lead INDUSTRY

Principal Investigators

  • Lluis Puig, MD, PhD · Universitat Autonoma de Barcelona (UAB)

  • Alberto Calligaro, MD, PhD · University of Pavia

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2019-06-30
Completion
2019-10-30

Countries

  • Italy
  • Kuwait

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03809416 on ClinicalTrials.gov