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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03522922
• Other study ID #: MNC.001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 1, 2016
• Est. completion date: March 31, 2018

Study information

• Verified date: April 2018
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 31, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Acne Scars
• Acne Vulgaris

Intervention

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

Locations

Country	Name	City	State
Egypt	Sohag Faculty of Medicine	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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