Clinical trial NCT02798016: Treatment of Atrophic Acne Scars With Platelet-Rich Plasma and Skin Needling
Official title: Treatment of Atrophic Acne Scars With Platelet-Rich Plasma Alone or in Combination With Skin Needling: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrophic Acne Scars
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2016-06-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Scar Appearance
timeFrame: 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 outcomes:
measure: Patients' Satisfaction
timeFrame: This is going to be assessed six months following the application of the intervention and the active comparator
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Dermatology and Venereology
Study officials:
affiliation: Associate Professor of Dermatology and Veneology, Medical School, University of Damascus
name: Faiez Al-Deghlaoui, MD MSc PhD
role: STUDY_DIRECTOR
References:
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. doi: 10.1111/j.1365-2230.1994.tb01200.x.
citation: 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. doi: 10.1136/bmj.1.6171.1109.
citation: Goulden V, Stables GI, Cunliffe WJ. Prevalence of facial acne in adults. J Am Acad Dermatol. 1999 Oct;41(4):577-80.
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. doi: 10.4103/0970-9290.38931.