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

Primary Purpose

Acne Vulgaris, Acne Scars

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Dermaroller
Topical Vitamin C
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne scars, dermaroller, vitamin C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Sohag Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Dermaroller arm

Dermaroller + topical Vit. C arm

Topical Vit. C arm

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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%)]

Full Information

First Posted
March 4, 2018
Last Updated
April 30, 2018
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT03522922
Brief Title
Efficacy of Microneedling With Topical Vitamin C in Treatment of Acne Scarring
Official Title
Efficacy of Microneedling With Topical Vitamin C in Treatment of Acne Scarring
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
March 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris, Acne Scars
Keywords
Acne scars, dermaroller, vitamin C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dermaroller arm
Arm Type
Active Comparator
Arm Description
Patients received a series of six treatments by dermaroller at 4 weeks interval and no topical anti scar treatment in between sessions.
Arm Title
Dermaroller + topical Vit. C arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Topical Vit. C arm
Arm Type
Active Comparator
Arm Description
Patients received once daily topical vitamin C serum capsule at night for six months. With monthly evaluation.
Intervention Type
Device
Intervention Name(s)
Dermaroller
Intervention Description
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
Drug
Intervention Name(s)
Topical Vitamin C
Other Intervention Name(s)
Topical Vit.C
Intervention Description
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
Primary Outcome Measure Information:
Title
Clinical response by (ECCA) scale
Description
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)
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Patient satisfaction questionnaire
Description
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%)]
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramadan Saleh, MD
Organizational Affiliation
Sohag Faculty of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Sohag Faculty of Medicine
City
Sohag
ZIP/Postal Code
82524
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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