A Phase 2 interventional study of Scar subcision and Platelet rich plasma injection in Atrophic Acne Scar, sponsored by Al-Azhar University. Not yet recruiting. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-01-29.
Sponsored by Al-Azhar University · Phase 2, Interventional, and Treatment
Many methods utilize for acne scar treatment including laser, cosmetic filler, microneedling, local tumescent, Subcision and chemical peels. These procedures can be used individually or as a combination therapy.
Combining procedures give better results. In our study we will try in the period from March 2024 to March 2026, to assess the efficacy of combination of scar subcision with platelet rich plasma, Polydioxanone mono threads or fractional Carbon dioxide laser in the treatment of severe atrophic acne scars with 1:1:1 ratios and to compare between these modalities regarding safety and efficacy.
This is a prospective controlled trial that will be conducted at Dermatology, venereology, and andrology Department, Al-Azhar university hospital, Assiut, in the period from March 2024 to March 2026, to assess the efficacy of combination of scar subcision with platelet rich plasma , polydioxanone mono threads or fractional carbon dioxide laser in the treatment of severe atrophic acne scars with 1:1:1 ratios and to compare between these modalities regarding safety and efficacy
828 studies on the registry are indexed under Atrophy; 122 are open to participants now.
This study's planned enrollment of 48 is above the median of 34 across 603 interventional studies indexed under Atrophy.
Browse Atrophy studies →Al-Azhar University is the lead sponsor of 505 studies on the registry; 167 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
3 sessions of scar subcision with platelet rich plasma injection at the same session with one month interval
Procedure: Scar subcision · Procedure: Platelet rich plasma injection
3 sessions of scar subcision followed by the insertion of Polydioxanone mono threads after the last session
Procedure: Scar subcision · Procedure: Polydioxanone mono threads insertion
3 sessions of scar subcision with Fractional carbon dioxide laser at the same session with one month interval
Procedure: Scar subcision · Device: Fractional carbon dioxide laser
* Subcision will be performed with18 gauge cannula at the margin of the scars on both sides of the face. * The cannula will be directed in a forward and backward motion producing a tunnel. Then, the it will be passed in sideways in a sweeping action to freeing up the scars from their bases. * Once finish, the pressure will be applied to reduce the bleeding and swelling. The topical antibiotic will be applied for 3 days.
• 20 ml of autologous whole blood will be collected into tubes containing acid citrate dextrose and centrifuged at 1500 rpm for 10 minutes in order to get PRP at the top of the test tube. Then, the PRP will be further centrifuged at 3700 rpm for 10 minutes at room temperature of 22°C in order to obtain a platelet count 4.5 times higher than the base line. Platelet-poor plasma (PPP) will be partly removed and partly used to resuspend the platelets. Calcium gluconate will be added as an activator (1:9), i.e., 1 ml of calcium gluconate in 9 ml of PRP
* Topical anesthetic cream will be applied for halfan hour on the involved area. * polydioxanone mono threads (50 mm, 27 G) will be inserted at 1-cm spacing into the dermal layer of the skin; the threads will be arranged in a transverse and vertical line in the form of a mesh similar to cross-hatching technique. * The total numbers will range from 8 to 10 each side. The skin of the face will be stretched by the non-dominant hand of the physician and the needle will be inserted by the other hand through the required point.
* Topical anesthetic cream will be applied for 30 minutes before the procedure. * BX300 device from AMI inc.,Korea will be used. * Different settings will be used according to each individual case regarding the type of scar, severity and skin type fluence ranging from 36 to 42 j/cm2 will be used and pulse duration 1.8 ms. * In an attempt to avoid common side effects that occur with fractional laser treatment, a lower fluence will be used in the first session and depending on the results, the fluence will be increased per treatment session.
Management of severe atrophic acne scars
to assess the efficacy of the combination of subcision with Platelet rich plasma, Polydioxanone mono threads or fractional carbon dioxide laser in the treatment of severe atrophic acne scars (As per Goodman and Baron's acne qualitative scar grading scale)
Time frame: 2 years
Comparing the 3 lines
to compare between the combination of subcision with Platelet rich plasma, Polydioxanone mono threads or fractional carbon dioxide laser in the treatment of severe atrophic acne scars regarding efficacy and safety. (As per Goodman and Baron's acne qualitative scar grading scale)
Time frame: 2 years
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Al-Azhar University