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

Phase 1

Completed

• Conditions: Acne Vulgaris; Acne Scars
• Interventions: Device: Dermaroller; Drug: Topical Vitamin C

• Registration Number: NCT03522922
• Lead Sponsor: Sohag University

Brief Summary

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

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

Study Timeline

• Study Start: 2016-06-01
• Primary Completion: 2018-02-01
• Study First Submitted: 2018-03-04
• Study Completion: 2018-03-31
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-30
• Last Update Submitted: 2018-04-30
• Study First Posted: 2018-05-14
• Last Update Posted: 2018-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dermaroller arm	Dermaroller	Patients received a series of six treatments by dermaroller at 4 weeks interval and no topical anti scar treatment in between sessions.
Dermaroller + topical Vit. C arm	Dermaroller	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.
Dermaroller + topical Vit. C arm	Topical Vitamin C	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.
Topical Vit. C arm	Topical Vitamin C	Patients received once daily topical vitamin C serum capsule at night for six months. With monthly evaluation.

Primary Outcome Measures

Name	Time	Method
Clinical response by (ECCA) scale	9 months	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)

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction questionnaire	9 months	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: \[(Excellent (100% -76%)- Very Good (51% - 75%) -good (26% - 50%)- poor (0% - 25%)\]

Trial Locations

Locations (1)

Sohag Faculty of Medicine; 🇪🇬 Sohag, Egypt