Atrophic Acne Scars
Conditions
Keywords
Acne- atrophic scars - autologous fat
Brief summary
This single-center, clinical trial consists of a one autologous fat grafting treatment followed by1-week , 1month , 3-month and 6-month post-treatment visits in order to assess the efficacy and complications of fat grafting when used for facial atrophic acne scars on cheeks.
Detailed description
This investigation, pilot study will evaluate the safety and efficacy of autologous fat grafting for the treatment of atrophic acne scarring on cheeks. Overall assessment of clinical outcome and safety will be based clinic visits and evaluation of pre- and post- procedural on the Goodman-Barron scale. The subject's assessment of satisfaction will be characterized using a non-parametric assessment scale at the end of the follow-up period.
Interventions
PROCEDUREFat Grafting
This single-center, clinical trial will assess the efficacy and tolerability of the autologous fat grafting when used on men and women with atrophic acne scars on the cheeks
Sponsors
Damascus University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients with atrophic post acne scars on the cheeks, between 20 - 40 years old * Not to apply other treatments a month before the procedure * Informed consent to enter the study
Exclusion criteria
* First grade of Goodman - Barron scale. * A systemic or associated skin disease that may affect the results of the study * patients with chronic consumption of nonsteroidal anti-inflammatory drugs (NSAIDs) or other non-aggregating agents. * Patients with acne in the acute stage * Pregnancy and breastfeeding * Tendency to form keloids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| • Change in atrophic acne scars assessment | Baseline and 6 Months | Acne scars will be used to evaluate efficacy of treatment using the Goodman- Barron scale \[which is an acne scars severity scale divided into 4 grades * First grade consists of hyper-or hypopigmented flat marks * Second grade consists of mild atrophy or hypertrophy that may not be obvious at social distances of 50 cm or greater and may be covered adequately by makeup * Third grade consists of moderate atrophic or hypertrophic scarring that is obvious at social distances of 50 cm or greater and is not covered easily by makeup or the normal shadow * Fourth grade severe atrophic or hypertrophic scarring that is obvious at social distances of 50 cm or greater and is not covered easily by makeup or the normal shadow\]. The grade of acne scars from final visit will be compared to their baseline grade visually evaluated by the study team. |
| Change in patient satisfaction | 3 Months, and 6 Months | The modified global aesthetic improvement scale for patient evaluation module which consists of 5 degrees * Exceptionally improved \[The ideal result has been achieve\] * much improved\[The result is much improved but suboptimal\] * Improved\[The result is improved but an additional procedure is recommended \] * no difference\[The result is the same when compared with the preoperative state\] * Worse\[The result is worse when compared with the preoperative state\] This module will be administered 3monts and 6 months postoperatively to analyze satisfaction and aesthetic perception of the result. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Erythema Presence | Baseline ,1 week ,1 month,3 months and 6 Months | Patients will be examined after procedure to check erythema presence and will be monitored until it will disappear |
| Change in Infection existence | 1 week, 1 month, 3 months and 6 Months | Patients will be examined after procedure to check existence of infection and will be monitored until it will heal. |
| Change in Irregularity Presence | Baseline and 6 Months | Patients will be examined after procedure to check irregularity presence at the end of the study |
| Change in Swelling Status | Baseline ,1 week 1month,3 months and 6 Months | Patients will be examined after procedure to check swelling status and will be monitored until it will disappear |
| Change in Bruising Status | Baseline ,1 week 1 month,3 months and 6 Months | Patients will be examined after procedure to check bruising status and will be monitored until it will disappear |
Countries
Syria
Outcome results
None listed