scars Acne vulgaris
Conditions
Interventions
Twenty adult participants with atrophic facial acne scars will be enrolled. Each participant will receive both study interventions, one on each hemiface, according to prior randomization: microneedlin
ANVISA Registration No. 80669600001). Multiple passes will be performed in horizontal, vertical, and diagonal directions using a back-and-forth motion until uniform purpura is achieved, which will be
Sponsors
Universidade Federal de São Paulo
Universidade Federal de São Paulo
Eligibility
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Patients with atrophic facial acne scars; absence of active inflammatory acne lesions; age between 18 and 55 years; Fitzpatrick skin phototypes I to IV.
Exclusion criteria
Exclusion criteria: Participants with active acne; history of hypertrophic scars or keloids; pregnant or breastfeeding women; active systemic infection; use of anticoagulants or immunosuppressive medications; autoimmune diseases; infectious or inflammatory dermatoses affecting the face; facial procedures performed within the previous 6 months; comorbidities that may interfere with the wound healing process; withdrawal of informed consent at any time during the study; withdrawal by the investigator due to the occurrence of adverse events or the need for medications that may impair the wound healing process.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A difference in efficacy between microneedling and fractional ablative CO2 laser in the treatment of atrophic facial acne scars is expected, as assessed using the Échelle d'Évaluation Clinique des Cicatrices d'Acné (ECCA), by comparing the scores obtained at baseline and one month after the final treatment session for each hemiface | — |
Secondary
| Measure | Time frame |
|---|---|
| Global clinical improvement is expected, as assessed using the Global Aesthetic Improvement Scale (GAIS), by comparing post-treatment findings with baseline photographs one month after the final treatment session;Clinical improvement in atrophic acne scars is expected, as assessed using the Goodman and Baron Qualitative and Quantitative Acne Scar Grading Systems, by comparing baseline assessments with those performed one month after the final treatment session;Improved participant-perceived treatment outcome is expected, as assessed by the participant's subjective evaluation, by comparing post-treatment perception one month after the final treatment session with baseline clinical status;An increase in dermal thickness and echogenicity is expected, as assessed by high-resolution ultrasonography (Dermascan®), by comparing baseline assessments with those performed one month after the final treatment session;Improvement in skin surface texture and a reduction in acne scar depth are expected, as assessed by skin surface profilometry using the Visioscan® system, by comparing baseline assessments with those performed one month after the final treatment session;An improvement in quality of life is expected, as assessed using the Dermatology Life Quality Index (DLQI), as demonstrated by a reduction in DLQI scores one month after the final treatment session compared with baseline;Espera-se observar aumento da qualidade e da densidade das fibras colágenas e elásticas, verificado por meio de análises histológica e imuno-histoquímica das biópsias obtidas antes do tratamento e um mês após a última sessão, comparando-se os achados pré e pós-tratamento;An increase in the expression of type I and type III collagen genes is expected, as assessed by reverse transcription quantitative polymerase chain reaction (RT-qPCR), by comparing gene expression levels in biopsy specimens obtained at baseline and one month after the final treatment session;The safety profile of the procedures | — |
Countries
BR
Contacts
Public ContactAna Luiza Mapurunga Gonçalves
Universidade Federal de São Paulo
Outcome results
None listed