Acne VulgarisPhase 1/2NCT03522922
Efficacy of Microneedling With Topical Vitamin C in Treatment of Acne Scarring
A Phase 1/2 study testing Dermaroller and Topical Vitamin C in people with Acne Vulgaris and Acne Scars, run by Sohag University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acne Vulgaris, Acne Scars
- What is being tested?
- Dermaroller and Topical Vitamin C
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2016to 31 Mar 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Facial acne scars
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- Clinical evaluation by B) Photographic documentation C) Patient satisfaction D) Safety assessment
- Conditions
- Acne Vulgaris, Acne Scars
- Being tested
- Dermaroller, Topical Vitamin C
- Keywords
- Acne scars, dermaroller, vitamin C
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermarollerDevice
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 CDrug
Also called Topical Vit.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
| Study group | Role | What they receive |
|---|---|---|
| Dermaroller arm | Active comparator | Patients received a series of six treatments by dermaroller at 4 weeks interval and no topical anti scar treatment in between sessions. Receives: Device: Dermaroller |
| Dermaroller + topical Vit. C arm | Active comparator | 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. Receives: Device: Dermaroller; Drug: Topical Vitamin C |
| Topical Vit. C arm | Active comparator | Patients received once daily topical vitamin C serum capsule at night for six months. With monthly evaluation. Receives: Drug: Topical Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 9 months
Secondary outcomes (1)
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%)]
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start1 Jun 2016
- Primary completion1 Feb 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasha Ismail, Sohag University
- Investigators
- Ramadan Saleh, MD, Study director, Sohag Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522922
- Sponsor's protocol ID
- MNC.001
- Status last verified
- Apr 2018
- First submitted
- 4 Mar 2018
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Share any information about the study with other researchers after acceptance of all authors.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Microneedling With Topical Vitamin C in Treatment of Acne Scarring
- ClinicalTrials.gov ID
- NCT03522922
- Acronym / sponsor ID
- MNC.001
- Conditions
- Acne Vulgaris, Acne Scars
- Keywords
- Acne scars, dermaroller, vitamin C
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 14 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Clinical evaluation by B) Photographic documentation C) Patient satisfaction D) Safety assessment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dermaroller arm | Active comparator | Device: DermarollerPatients received a series of six treatments by dermaroller at 4 weeks interval and no topical anti scar treatment in between sessions. |
| Dermaroller + topical Vit. C arm | Active comparator | Device: Dermaroller, Drug: Topical Vitamin CPatients 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. |
| Topical Vit. C arm | Active comparator | Drug: Topical Vitamin CPatients received once daily topical vitamin C serum capsule at night for six months. With monthly evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Facial acne scars
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DermarollerThe 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. | Device | Dermaroller + topical Vit. C arm, Dermaroller arm |
| Topical Vitamin CAlso: Topical Vit.CThe 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 | Drug | Dermaroller + topical Vit. C arm, Topical Vit. C arm |
Primary outcome
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)
1 secondary outcome
Patient satisfaction questionnaire
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
- Individual participant dataSharing planned: Yes. Share any information about the study with other researchers after acceptance of all authors.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramadan Saleh, MD study director
Sohag Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dermaroller and Topical Vitamin C in people with Acne Vulgaris and Acne Scars, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response by (ECCA) scale (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2018.