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Completed

NCT Number: NCT03522922

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.

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Key information

Conditions

Acne Vulgaris Acne Scars Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Sohag Faculty of Medicine

Sohag, 82524, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Dermaroller

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

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

Other names: Topical Vit.C

Primary outcomes

  1. Clinical response by (ECCA) scale

    Time frame: 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 outcomes

  1. Patient satisfaction questionnaire

    Time frame: 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%)]

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 14, 2018
Registry last updated
May 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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