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Trial record 18 of 82 for:    acne AND Acne Scars

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

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ClinicalTrials.gov Identifier: NCT03522922
Recruitment Status : Completed
First Posted : May 14, 2018
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Rasha Ismail, Sohag University

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.


Condition or disease Intervention/treatment Phase
Acne Vulgaris Acne Scars Device: Dermaroller Drug: Topical Vitamin C Phase 1 Phase 2

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Microneedling With Topical Vitamin C in Treatment of Acne Scarring
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : February 1, 2018
Actual Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars Vitamin C

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 Name: 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 Name: Topical Vit.C




Primary Outcome Measures :
  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 Outcome Measures :
  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%)]



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522922


Locations
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Egypt
Sohag Faculty of Medicine
Sohag, Egypt, 82524
Sponsors and Collaborators
Sohag University
Investigators
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Study Director: Ramadan Saleh, MD Sohag Faculty of Medicine

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Responsible Party: Rasha Ismail, Assistant lecturer, Department of Dermatology, Venereology and Andrology, Sohag University
ClinicalTrials.gov Identifier: NCT03522922     History of Changes
Other Study ID Numbers: MNC.001
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Share any information about the study with other researchers after acceptance of all authors.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will become available by the end of April 2018, without time frame.
Access Criteria: To all interested researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rasha Ismail, Sohag University:
Acne scars
dermaroller
vitamin C

Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Vitamins
Ascorbic Acid
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents