Treatment of Striae Alba
Conditions
Brief summary
The aim of this study is to evaluate the efficacy and safety of Microneedling with Phenytoin versus Microneedling alone for the Treatment of Striae alba.The study is a comparative study which will be carried on 30 patients with Striae alba. Each patient will receive four sessions three weeks apart of the following treatment: -Right side: striae on the right side will be treated by microneedling with depth (2 mm)with topical phenytoin 2% solution. -Left side: striae on the left side will be treated by microneedling alone with depth (2 mm) . The follow up will be during each session and 1 months after the last session. For treated striae alba, Microneedling will be done under aseptic conditions using isopropyl alcohol 70%.
Detailed description
The aim of this study is to evaluate the efficacy and safety of Microneedling with Phenytoin versus Microneedling alone for the Treatment of Striae alba.The study is a comparative study which will be carried on 30 patients with Striae alba. Each patient will receive four sessions three weeks apart of the following treatment: -Right side: striae on the right side will be treated by microneedling with depth (2 mm)with topical phenytoin 2% solution. -Left side: striae on the left side will be treated by microneedling alone with depth (2 mm) . The follow up will be during each session and 1 months after the last session. For treated striae alba, Microneedling will be done under aseptic conditions using isopropyl alcohol 70%. All Patients will be evaluated during each session and 1 month after the last session. All patients in this study will be subjected to the following: 1. Written informed consent will be obtained from all patients after informing them about the steps of the procedures, the expected effects, the possible complications, other alternative treatments, and the importance of photo documentation. 2. Full history taking: * Personal history: Name, age, sex, residency, marital status, education, socio-economic status, special habits of medical importance, and occupational history. * Present history: including onset, course, and duration of the lesions. * Past history of any medical, or dermatological diseases and drug history. 3. clinical Examination: \*General examination: to detect any associated dermatological or systemic disorders. 4. Local dermatological examination for detection of site, size, distribution and severity of stria alba . * Detect severity of striae by Imam, Nelva, Alviera score (INA score) - Number of striae distensae lines, size of the longest striae distensae line, color and presence or absence of itching. The degrees of severity can be calculated per region are mild (score \<3),moderate( score3-6)and sever (score \>6). The follow-up will include the following assessments: Evaluation by 1\. Evaluation by Digital Photography Standardized high-resolution digital photographs taken before and after treatment under consistent lighting conditions. 2- Evaluation by Detect severity of striae by Imam, Nelva, Alviera score (INA score) 3-Evaluation of pain subject discomfort will assessed using a 10-centimeter Visual Analog Scale (VAS) on a scale from 0 cm (no pain) and 10 cm (pain as bad as it can be), 0-0.4 cm: No pain, 0.5-4.5 cm: Mild pain, 4.6-7.5 cm: Moderate pain, 7.6-10 cm: Severe pain 4 -Evaluation of Patient satisfaction (PS score) was recorded using the following scale: 0 (not satisfied), 1 (slightly satisfied), 2 (satisfied), 3 (very satisfied), 4 (extremely satisfied). 5-Patients will be assessed for any adverse effects including pain, edema, erosion, necrosis, and hyperpigmention.
Interventions
DRUGPhenytoin
striae on the right side will be treated by microneedling with depth (2 mm)with topical phenytoin 2% solution. A 2% Phenytoin topical solution will be prepared by dissolving the accurate amount of Phenytoin sodium in purified water using a magnetic stirrer. 15% propylene glycolwill be added to this solution as a cosolvent and a viscosity modifier. The formulation will be stirred using magnetic stirring up to complete dissolving. Finally, the prepared solution will be dispensed in an amber-colored glass bottle.
DEVICEMicro needling
striae on the left side will be treated by microneedling alone with depth (2 mm) .
Sponsors
Al-Azhar University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Each patient will receive four sessions three weeks apart of the following treatment: -Right side: striae on the right side will be treated by microneedling with depth (2 mm)with topical phenytoin 2% solution. A 2% Phenytoin topical solution will be prepared by dissolving the accurate amount of Phenytoin sodium in purified water using a magnetic stirrer. 15% propylene glycol will be added to this solution as a cosolvent and a viscosity modifier. The formulation will be stirred using magnetic stirring up to complete dissolving. Finally, the prepared solution will be dispensed in an amber-colored glass bottle.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients with stria alba. * The patient's age ≥18 years. * Both sex male and Femal patients * At least 3 stria
Exclusion criteria
* Pregnancy or lactation. * Keloid or hypertrophic scar tendency * Active skin infection at treatment site * Use of isotretinoin within the past 6 months * Bleeding disorders or anticoagulant therapy * History of hypersensitivity to phenytoin * Chronic systemic diseases affecting wound healing (e.g., uncontrolled diabetes) * Previous striae treatment within the last 6 months * Unrealistic expectations or poor compliance * Premalignant or malignant lesions in the treatment area
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in INA score of striae alba between treatment sides | baseline (before Session 1) and Week 9 (after completion of Session 4) | Change in the INA score of striae alba from baseline to after completion of the four treatment sessions for each treatment side. The change in INA score will be compared between the right side treated with micro needling plus topical phenytoin and the left side treated with micro needling alone., |
| Change in INA score of striae Alba between treatment sides. | Baseline (before Session 1), and 1 month after the last treatment session(weak 13). | \- The change in (INA) score of striae alba from baseline and 1 month after the last session for each treatment side. The change in INA score will be compared between the right side treated with microneedling plus topical phenytoin and the left side treated with microneedling alone. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain score | During each treatment session at Baseline (before Session 1), Week 3 (before Session 2), Week 6 (before Session 3), and Week 9 (before Session 4). | Pain intensity will be assessed using a visual analogue scale (VAS)on a scale from 0 cm (no pain) and 10 cm (pain as bad as it can be), 0-0.4 cm: No pain, 0.5-4.5 cm: Mild pain, 4.6-7.5 cm: Moderate pain, 7.6-10 cm: Severe pain during each treatment session for both treatment sides. Pain scores will be compared between the right side treated with microneedling plus topical phenytoin and the left side treated with microneedling alone. |
| Change in Patient Satisfaction (PS) Score | Baseline, after treatment at fourth session(weak 9) , and 1 month after the last treatment session(weak13). | Patient satisfaction will be assessed using the Patient Satisfaction (PS) score 0 (not satisfied), 1 (slightly satisfied), 2 (satisfied), 3 (very satisfied), 4 (extremely satisfied) after treatment( weak 9), and 1 month after the last treatment session for each treatment side. Changes in PS scores will be compared between the right side treated with micro needling plus topical phenytoin and the left side treated with micro needling alone. |
Countries
Egypt
Outcome results
None listed