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

NCT ID: NCT03522922

Last Updated: 2018-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2018-03-31

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

Conditions

Acne Vulgaris; Acne Scars

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dermaroller arm

Patients received a series of six treatments by dermaroller at 4 weeks interval and no topical anti scar treatment in between sessions.

Group Type: ACTIVE_COMPARATOR

Dermaroller

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

Dermaroller

Intervention Type: DEVICE

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.

Topical Vitamin C

Intervention Type: DRUG

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

Topical Vit. C arm

Patients received once daily topical vitamin C serum capsule at night for six months. With monthly evaluation.

Group Type: ACTIVE_COMPARATOR

Topical Vitamin C

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DEVICE

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

Intervention Type: DRUG

Other Intervention Names

Topical Vit.C

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Rasha Ismail

Assistant lecturer, Department of Dermatology, Venereology and Andrology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ramadan Saleh, MD

Role: STUDY_DIRECTOR

Sohag Faculty of Medicine

Locations

Sohag Faculty of Medicine

Sohag, , Egypt

Countries

Egypt

Other Identifiers

MNC.001

Identifier Type: -

Identifier Source: org_study_id