Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02798016
Other study ID # UDMS-Dermat-01-2016
Secondary ID
Status Completed
Phase N/A
First received May 13, 2016
Last updated December 31, 2017
Start date October 2015
Est. completion date October 20, 2017

Study information

Verified date December 2017
Source Damascus University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Investigators will collect blood specimens from the participating patients and then blood samples will be centrifuged in order to collect platelet-rich plasma which is going to be injected in the atrophic acne scars. A split-face design is going to used in this randomized controlled trial. In the control side of the face, micro-needling to the skin will occur using a specific tool (Dermapen).


Description:

Atrophic acne scar is a common problem with a challenging treatment. Platelet-rich plasma (PRP) is an autologous preparation of platelets in concentrated plasma that may be beneficial in the treatment of atrophic acne scars by promoting collagen deposition.

Skin needling is a technique that uses a sterile micro needles to puncture the skin and release growth factors. The combination of skin needling and PRP could enhance the efficacy of both modalities.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date October 20, 2017
Est. primary completion date June 23, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Atrophic acne scars on both sides of the face

Exclusion Criteria:

- patients with active acne, herpes labialis, or bacterial infection; warts on the face, actinic keratosis, or skin cancer

- systemic retinoids intake in the previous 6 months,

- diabetes, pregnancy, history of keloidal scarring; or patients with severe systemic illness or malignancy

- patients on anticoagulant therapy or aspirin or have a coagulation issue,

- patients with hemoglobin less than 10g\dl or platelet less than 105 micron\l

- any previous procedures for acne scar within the last 6 months

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Platelet-Rich Plasma
This Platelet-Rich Plasma will be taken from each patient and is going to be used in the treatment of atrophic acne scars
Micro-needling
Micro-needling will be applied on the acne scars in one side of the face.

Locations

Country Name City State
Syrian Arab Republic Department of Dermatology and Venereology Damascus

Sponsors (1)

Lead Sponsor Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (4)

Cunliffe WJ, Gould DJ. Prevalence of facial acne vulgaris in late adolescence and in adults. Br Med J. 1979 Apr 28;1(6171):1109-10. — View Citation

Goulden V, Stables GI, Cunliffe WJ. Prevalence of facial acne in adults. J Am Acad Dermatol. 1999 Oct;41(4):577-80. — View Citation

Layton AM, Henderson CA, Cunliffe WJ. A clinical evaluation of acne scarring and its incidence. Clin Exp Dermatol. 1994 Jul;19(4):303-8. — View Citation

Sunitha Raja V, Munirathnam Naidu E. Platelet-rich fibrin: evolution of a second-generation platelet concentrate. Indian J Dent Res. 2008 Jan-Mar;19(1):42-6. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Scar Appearance Scar Appearance will be assessed at: T1; one day (wihtin 24 hours) before the application of the intervention(s); and T2: after three months of applying the intervention(s).
Secondary Patients' Satisfaction The assessment will be based on a questionnaire This is going to be assessed six months following the application of the intervention and the active comparator
See also
  Status Clinical Trial Phase
Completed NCT02643628 - A Pilot Study to Evaluate the Safety and Effectiveness of Microneedling and Bellafill to Treat Facial Acne Scars N/A
Recruiting NCT05995340 - ELAPR002f Injectable Gel in the Treatment of Atrophic Acne Scars Phase 3
Active, not recruiting NCT01773343 - Treatment of Atrophic Acne Scars With a Fractional CO2 Laser at 1 Versus 3 Months Intervals N/A
Completed NCT02145364 - Ultherapy® for the Treatment of Acne Scars N/A
Completed NCT02735421 - Adapalene 0.3% - Benzoyl Peroxide 2.5% Gel and Risk of Formation of Atrophic Acne Scars Phase 4
Completed NCT05028283 - Treatment of Atrophic Post Acne Scars by Fat Grafting N/A
Completed NCT06002854 - Comparison Of Outcome Of Microneedling With Autologous PRP Vs Microneedling With Topical Insulin In Treatment Of Post Acne Atrophic Scars. Phase 2