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

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.

Study Overview

• Status: Completed
• Conditions: Acne Scars; Acne Vulgaris
• Intervention / Treatment: Device: Dermaroller; Drug: Topical Vitamin C

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt, 82524
    • Sohag faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dermaroller arm; Patients received a series of six treatments by dermaroller at 4 weeks interval and no topical anti scar treatment in between sessions.	Device: Dermaroller; 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.
Active Comparator: Dermaroller + topical Vit. C arm; 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; 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.; Drug: Topical Vitamin C; 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; Other Names: Topical Vit.C
Active Comparator: Topical Vit. C arm; Patients received once daily topical vitamin C serum capsule at night for six months. With monthly evaluation.	Drug: Topical Vitamin C; 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; Other Names: Topical Vit.C

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Study Director: Ramadan Saleh, MD, Sohag faculty of medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): March 31, 2018

Study Registration Dates

• First Submitted: March 4, 2018
• First Submitted That Met QC Criteria: April 30, 2018
• First Posted (Actual): May 14, 2018

Study Record Updates

• Last Update Posted (Actual): May 14, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: dermaroller; vitamin C; Acne scars
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid
• Other Study ID Numbers: MNC.001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Share any information about the study with other researchers after acceptance of all authors.
• IPD Sharing Time Frame: Data will become available by the end of April 2018, without time frame.
• IPD Sharing Access Criteria: To all interested researchers
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No