Efficacy of Microneedling With Topical Vitamin C in Treatment of Acne Scarring

Study Overview
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Brief Summary
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This study aimed to evaluate the efficacy of dermaroller and topical vitamin C- either separate or combined- in treatment of post acne scars. prospective randomized clinical trial that was The study was a randomized controlled trial, conducted in Sohag Dermatology outpatient clinic between June 2016 and of February 2018. 30 patients with acne scars were included. All patients were informed about the entire procedure, medication, possible side effects and outcomes. A written informed consent was signed from each participant.

Detailed Description
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Study population: Each study group included 10 patients. Detailed history and full clinical examination was conducted for each patient. Patients had 6 visits at one month interval to receive treatment and evaluated one month after the end of treatment visits. The first group: Patients received a series of six treatments by dermaroller at 4 weeks interval and no topical anti scar treatment in between sessions. The second group: Received a series of six treatments by dermaroller at 4 weeks interval with the same maneuver and instructions as first group and each session was followed by immediate application of topical vit.C serum plus once daily application in between sessions. The third group: received once daily topical vit.C serum capsule at night for six months. With monthly evaluation. Assessment of patients during visits was as follow: A) Clinical evaluation by B) Photographic documentation C) Patient satisfaction D) Safety assessment

Official Title
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Efficacy of Microneedling With Topical Vitamin C in Treatment of Acne Scarring

Conditions
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Acne Vulgaris, Acne Scars

Intervention / Treatment
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* Device: Dermaroller
* Drug: Topical Vitamin C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Facial acne scars Exclusion Criteria: Active inflammatory acne. Active infection in the treatment area (e.g., herpes simplex and verrucae). Melanoma or lesions suspected of malignancy. Isotretinoin use in the past year. Dermatoses (e.g., eczema and psoriasis). Sunburn. Anticoagulant therapy. Systemic disease (diabetes, hypertension, collagen disease or bleeding tendency).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dermaroller arm<br>Patients received a series of six treatments by dermaroller at 4 weeks interval and no topical anti scar treatment in between sessions. | Device: Dermaroller<br>* The derma roller used (dermaroller MF8, MT dermaroller Beverly Hills, California USA) is a plastic device with a 12-cm handle that holds a drum-shaped cylinder at the end, similar to a small paint roller, 2 cm in diameter and 2 cm in width. The surface of the cylinder holds 192 titanium needles in eight rows. Each 0.25 mm in diameter and 1.5 mm length sterilized by UV/ Gamma rays.<br>|
| Active Comparator: Dermaroller + topical Vit. C arm<br>Patients received a series of six treatments by dermaroller at 4 weeks interval with the same maneuver and instructions as first group and each session was followed by immediate application of topical vitamin C serum plus once daily application in between sessions. | Device: Dermaroller<br>* The derma roller used (dermaroller MF8, MT dermaroller Beverly Hills, California USA) is a plastic device with a 12-cm handle that holds a drum-shaped cylinder at the end, similar to a small paint roller, 2 cm in diameter and 2 cm in width. The surface of the cylinder holds 192 titanium needles in eight rows. Each 0.25 mm in diameter and 1.5 mm length sterilized by UV/ Gamma rays.<br>Drug: Topical Vitamin C<br>* The used vitamin C product was in the form of 17% concentration of L- Ascorbic Acid serum that was encapsulated in gelatinous capsules each contain 1 mg of the serum. The patient instructed to open one capsule and apply its serum content on the treatment area daily at night. This capsule form for topical application help to insure stability of the product and also insure use of equal dose in each application<br>* Other names: Topical Vit.C;|
| Active Comparator: Topical Vit. C arm<br>Patients received once daily topical vitamin C serum capsule at night for six months. With monthly evaluation. | Drug: Topical Vitamin C<br>* The used vitamin C product was in the form of 17% concentration of L- Ascorbic Acid serum that was encapsulated in gelatinous capsules each contain 1 mg of the serum. The patient instructed to open one capsule and apply its serum content on the treatment area daily at night. This capsule form for topical application help to insure stability of the product and also insure use of equal dose in each application<br>* Other names: Topical Vit.C;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response by (ECCA) scale | Assessment of clinical response before intervention,after each session and at monthly intervals for 3 months after the end of sessions. Echellad'e valuation Clinique des cicatrices d'acne (ECCA) scale was used for numerical grading of acne scars.The ECCA grading scale is a tool designed to help dermatologists to assess the severity of acne scars and to standardize the discussions about the treatments of scars. The scale grades from no scar (grade = 0) to many scars (grade= 3) | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction questionnaire | Patient satisfaction at the end of study graded as one of four categories represents the % of subjective improvement in the acne scars after treatment as compared with prior to treatment: [(Excellent (100% -76%)- Very Good (51% - 75%) -good (26% - 50%)- poor (0% - 25%)] | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne scars, dermaroller, vitamin C