Acne Scars - Atrophic
Conditions
Brief summary
To compare the efficacy and safety of combined nanofat injection with either platelet rich fibrin or microneedling versus nanofat injection alone in the treatment of facial atrophic post acne scars.
Detailed description
Inflammatory acne lesions may result in permanent scars . Atrophic, hypertrophic, and keloidal scars are the categories into which acne scars can be generically divided . Atrophic scarring represents about 75% of acne scars and is subdivided into icepick, rolling, and boxcar scars . Currently, there is no standard treatment for atrophic acne scars. Various treatment approaches have been used to improve the appearance of acne scars, with varying degrees of success \]. Traditional treatment methods include lasers, platelet-rich plasma (PRP), excisions, skin abrasion, chemical peeling, tissue filling, microneedling, thread lifting, and photodynamic therapy, while emerging therapies such as mesenchymal stem cells (MSCs) and their derivatives are also available . Autologous fat grafting is an alternative modality in managing post acne scarring . In 2013, Tonnard was the first person who described the technique of obtaining nano fat. Its capacity for regeneration is attributable to the adipose tissue-derived stem cells (ADSCs) and stromal vascular fraction (SVF) cells that promote blood vessel formation and the secretion of growth factors that impede fibrosis and inflammation, speed up wound healing, and improve skin texture. Platelet-rich fibrin (PRF), the second-generation platelet concentrate, was developed for the purpose of removing anticoagulants and for better release of growth factors. A rapid and short centrifugation procedure is needed for separation of blood layers before clotting. A fibrin matrix is formed in the platelet-rich layer entrapping platelets and leukocytes in it. This matrix makes the release of growth factors slow and prolonged comparing with PRP . Microneedling (MN) therapy has been used as a treatment for various dermatological conditions, including scar tissue . This technique involves repetitive skin puncture using sterile microneedles to disrupt dermal collagen that connects the scar tissue. The needle will penetrate the stratum corneum and generate small holes with minimal damage to the epidermis. This process will provoke the regeneration of growth factors to stimulate collagen and elastin production . To the best of our knowledge, platelet rich fibrin and microneedling have never been tried with nanofat injection in the treatment of atrophic post acne scars and our study is the first to do so.
Interventions
PROCEDUREnanofat injecion
potential donor sites for fat graft including the lower abdomen, flanks, hips and thighs. After injection of 2 cm of lidocaine hydrochloride 2% intradermally at site of entry blade will be stabbed to open access for harvesting cannula to access subcutaneous fat. Tumescent anesthesia will be infiltrated in multidirectional plane to numb the whole area and waiting for 20 minutes, then starting to push the harvesting cannula in and out with slight suction pressure created by pulling the plunger of 20 ml luer-lock syringe, finally subcutaneous fat started to be expelled in the syringe The aspirated fat will be centrifuged at 3000 rpm for 3 min to concentrate fat particles Then the lipoaspirate will be mechanically emulsified using 2.4, 1.4, and 1.2 mm Luer-to-Luer Tulip connectors via 30 mechanical passes between two syringes through each connector, respectively A filtration process will be performed using a special filter containing a mesh with ultra-fine holes to remove debris
PROCEDUREPlatelet rich fibrin
PRF will be produced by single spin centrifugation of 10 ml of venous blood collected in plain glass tube without anticoagulant at 700 rpm for 3 min. The upper layer, yellow to orange colored fluid, will be collected as fluid PRF. Approximately, 1 ml Fluid PRF can be separated from 10 ml blood. * 45 min before the session, local anesthetic cream containing mixture of lidocaine and prilocaine will be applied to one side of the face, then will be sterilized by alcohol before starting the treatment. * one side of face will be treated by intradermal injection of fluid PRF. 0.1 mL of fluid PRF will be injected intradermally into the atrophic scars with 1.5 to 2 cm interval using insulin syringe followed by gentle massaging of the treated area. * The treatment will be started immediately after separation of PRF to avoid clot formation. The patients will receive three treatment sessions with 4 weeks interval
PROCEDUREMicroneedling
Microneedling will be done by Derma electric-pen, and needle cartridge with 12 needles. Needle length will be adjusted at 2.5 mm and speed level 4 (blue color). * 45 min before the session, local anesthetic cream containing mixture of lidocaine and prilocaine will be applied to one side of the face, then will be sterilized by alcohol before starting the treatment. Dermapen will be moved in the four directions, vertically, horizontally, diagonally right and left, over one side of the face without pressing. * The patients will receive three treatment sessions with 4 weeks interval
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Nanofat injection
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Patients older than 18 years of both sexes with moderate to severe atrophic facial acne scars on both cheeks
Exclusion criteria
* 1\. Patients' age \<18 or \>45 years 2. Pregnant and lactating women 3. active inflammatory acne or active infection in the treatment area. 4. treatment of the targeted study sites within 2 months 5. history of chronic diseases (autoimmune diseases, bleeding disorders, taking anticoagulant therapy or aspirin) 6. history of hypertrophic scars or keloid formation tendency. 7. patients with unrealistic expectations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| compare the efficacy and safety of combined nanofat injection with either platelet rich fibrin or microneedling versus nanofat injection alone in the treatment of facial atrophic post acne scars. | 6 months | Comaprison among different treatment modalities will be done by 1-Goodman and Baron qualitative score : Goodman and Baron qualitative Scale for each side of the face will be performed for all groups by counting and grading scars at the baseline and 3 months after the last session, then comparing its values before the start of treatment and 3 months after the last session Grade 1 (Macular): Erythematous, hyperpigmented, or hypopigmented flat marks. Grade 2 (Mild): Mild atrophic or hypertrophic scars, usually concealable with makeup or hair. Grade 3 (Moderate): Obvious, noticeable scars that are not easily hidden, sometimes showing "ice-pick" characteristics. Grade 4 (Severe): Marked, deep, or severe scarring, or widespread, severe scarring. Is nanofat injection alone effective in treamtment of post acne scars or when combined with either platelt rich fibrin or microneedling is better? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient's satisfaction | 6 months | Patients will be asked at their last follow-up visit to rate their improvement and aesthetic appearance of scars on each side of the face using the quartile scale (slight improvement \<25%, moderate improvement 25%-49%, significant improvement 50%-74%, and marked improvement ≥75%) |
| Pain assessment | 6 months | All patients will be asked to rate their pain on a scale of 0 to 10. 0 means no pain and 10 means the worst pain. Pain will be evaluated using a numerical 0 to 10 scale (0 = no pain, 1-4 = mild pain, 5-7 = moderate pain, and 8-10 = severe pain |
| Histopathological evaluation | 6 months | A 2 mm punch biopsies will be obtained from representative atrophic scars on each facial side at baseline (before treatment) and at the end of 6 months. All biopsies will be taken from scar tissue only. Biopsy sites will be standardized by selecting scars of comparable clinical type and severity on both cheeks. Specimens will include epidermis and extend to the mid-dermis.Tissues will be fixed in 10% neutral buffered formalin, routinely processed, and embedded in paraffin. Serial sections (4-5 μm) will be prepared. The following stains will be performed: * Hematoxylin and Eosin (H\&E) * Masson's Trichrome Histological Assessment Parameters: Epidermal Thickness, Dermal Architecture Assessment (H\&E), Collagen Deposition and Organization (Masson's Trichrome), Microvascular Density (H\&E Morphological Counting) and Inflammatory Infiltrate (H\&E) |
Contacts
CONTACTMarilyn Sameh Abd Almalak, Assistant lecturer
CONTACTEman Mohamed Kamal Elsayed Youssef, Professor
STUDY_DIRECTORRadwa Mohamed Abdel Moniem Bakr, Associate professor
STUDY_DIRECTORHowida Omar Mahmoud, Associate professor
STUDY_DIRECTOREman Mohamed Kamal Elsayed Youssef, Professor
unafflilted
Outcome results
None listed