Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000567224
Ethics application status
Approved
Date submitted
28/10/2016
Date registered
13/04/2018
Date last updated
24/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of efficacy of Micro needling with Platelet rich plasma versus Micro needling with Vitamin C for improvement in the appearance of Atrophic Facial Scars
Scientific title
Comparison Of efficacy of Micro needling with Platelet rich plasma versus Micro needling with Vitamin C in Treatment of Atrophic Facial Scars
Secondary ID [1] 288954 0
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Universal Trial Number (UTN)
U1111-1189-1805
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
atrophic facial scars 298324 0
post burn atrophic facial scars 298325 0
post trauma atrophic facial scars 298326 0
post acne atrophic facial scars 298327 0
post infectious e.g., chicken pox 298328 0
Condition category
Condition code
Skin 298445 298445 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
topical local anesthetic (5% EMLA cream) is applied over scars 45 mins before procedure. Autologous PRP is prepared during this time interval ( of EMLA application) before starting microneedling, All the procedures will performed by primary researcher. Micro needling is done on each scarred skin in vertical, horizontal and both diagonal directions for 4 times (standard application) at a depth of 1.5mm, then PRP is injected at 0.1 ml/cm2 (approximate dose) in group A patients while vitamin C(500mg) 0.1 ml/cm2 is injected over the scarred areas in group B patients and micro needling is repeated again as above. PRP is made by taking 20ml of blood through venous puncture, first soft spin is at 1500 resolutions/min(RPM) for 10 minutes and then second hard spin is at 2500RPM for 10 minutes. from this 20ml we get 4.5ml of PRP Ice packs will be applied over treated areas in both groups and strict photo protective measures are advised during course of treatment for all the patients. Total of 3 sessions 4 weeks apart are done in all the cases.
time duration of each session is one hour and thirty minutes
primary researcher is post graduate resident in plastic surgery department of Jinnah burn and reconstructive surgery center.
PRP is injected at 0.1 ml/cm2 in group A patients while vitamin C 0.1 ml/cm2 is injected over the scarred areas in group B patients both before and after microneedling..
strength of vitamin C injection used is 500mg
a total of 4.5ml of prp is obtained from 20ml of blood.
Intervention code [1] 294436 0
Treatment: Devices
Intervention code [2] 296246 0
Treatment: Other
Comparator / control treatment
Group A all patients are treated with microneedling at depth of 1.5mm before and after PRP injections in the deep dermis for a total of 3 sessions done at interval of 4 weeks each with a followup at 1 month after completion of treatment.
Control group
Active

Outcomes
Primary outcome [1] 300006 0
to compare the efficacy of microneedling with PRP vs microneedling with Vitamin C for improvement in scar quality and grade by Good Man and Baron Scale. (Goodman GJ, Baron JA. Postacne scarring: A qualitative global scarring grading system. Dermatol Surg 2006;32:1458-66)
Each patients were photographed and were assessed by a consultant Plastic Surgeon(who is blinded with the treatment modality used)
Timepoint [1] 300006 0
1 month after the end of treatment
Secondary outcome [1] 328793 0
to compare the efficacy of microneedling with PRP vs microneedling with Vitamin C for improvement in pigmentation of scarred area wiil be assessed by a consultant plastic surgeon (who is blinded) using hyperpigmentation scale proposed by Wang et al (Wang LZ, Ding JP, Yang MY, Chen DW, Chen B. Treatment of facial post-burn hyperpigmentation using micro-plasma radiofrequency technology. Lasers Med Sci DOI 10.1007/s10103-014-1649-6)
Timepoint [1] 328793 0
1 month after the end of treatment

Eligibility
Key inclusion criteria
1. Age above 10 years to 50 year/either sex
2. Goodman and baron II, III,IV scars.
3. Atrophic Scars more than 1 year
4. Post burn, trauma, surgery and acne atrophic scars over face
Minimum age
10 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Presence of active skin infections like acne, warts, herpes and bacterial infections (determined by history and clinical examination).
2. Keloid scarring/tendency (determined by history and clinical examination).
3. History of bleeding disorder and anticoagulant therapy determined on PT > 10 – 13 sec and INR > 0.9 - 1.2 sec
4. Oral steroid therapy determined on history.
5. Pregnant/lactating women or planning pregnancy will be determined on history

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation involved contacting the holder of the allocation schedule who was off-site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All the collected information from the proforma will be entered into S.P.S.S. version 17 and will be analyzed through its statistical package. Numerical variables of interest like age will be presented as mean and standard deviation. Nominal variables like gender, efficacy will be presented as frequency and percentage. Data will be stratified for age, gender and duration of scar, post stratification Chi square will be used to compare the efficacy in both groups with P = .05 as statistical significance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/11/2016
Date of last participant enrolment
Anticipated
Actual
10/04/2017
Date of last data collection
Anticipated
Actual
30/06/2017
Sample size
Target
60
Accrual to date
Final
57
Recruitment outside Australia
Country [1] 8356 0
Pakistan
State/province [1] 8356 0
Punjab

Funding & Sponsors
Funding source category [1] 294820 0
Hospital
Name [1] 294820 0
Jinnah Burn & Reconstructive Surgery Center
Country [1] 294820 0
Pakistan
Primary sponsor type
Individual
Name
Sania Ahmad
Address
Jinnah Burn & Reconstructive Surgery Center
Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road
Lahore, 54550
Country
Pakistan
Secondary sponsor category [1] 293665 0
Individual
Name [1] 293665 0
Farrukh Aslam Khalid
Address [1] 293665 0
Jinnah Burn & Reconstructive Surgery Center
Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road
Lahore, 54550
Country [1] 293665 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296211 0
Ethical Review Board of Jinnah Burn and Reconstructive Surgery Centre
Ethics committee address [1] 296211 0
Jinnah Burn & Reconstructive Surgery Center
Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road
Lahore, 54550
Ethics committee country [1] 296211 0
Pakistan
Date submitted for ethics approval [1] 296211 0
07/04/2016
Approval date [1] 296211 0
24/04/2016
Ethics approval number [1] 296211 0

Summary
Brief summary
After approval from Ethical committee of our hospital, 60 patients presenting in the Department of Plastic Surgery through outpatient department of Jinnah hospital, fulfilling the selection criteria will be included in the study. An informed consent will be obtained from them. Patients will be divided randomly in two groups by random number table; Group A, for micro needling with prp and group B, for micro needling with vitamin C. All the patients will be photographed and baseline assessment will be done before initiation of treatment by filling the proforma attached. All patients will receive a topical local anesthetics 5% EMLA cream for about 45min before procedure.PRP is obtained from patient’s own blood and activated by adding calcium gluconate as 1 ml in 9ml PRP. In both groups patients, micro needling is done in vertical, horizontal and both diagonal directions for 4 times at a depth of 1.5mm, then PRP is injected in group A patients while vitamin C is injected in group B patients and micro needling is repeated again as above. Ice packs will be applied over treated areas in both groups and strict photo protective measures are advised during course of treatment for all the patients.
A total of 3 similar sessions will be done at intervals of 4 weeks each. The scars will be assessed by 4 weeks after the end of these treatment sessions using Goodman and baron grading score . Photographs of pre and post treatment faces will be taken under consistent background, position and lighting for comparison. Effect modifiers like age, gender and duration of scar will be addressed through stratification. Data will be entered in the proforma .
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65034 0
Dr Sania Ahmad
Address 65034 0
Jinnah Burn & Reconstructive Surgery Center
Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road
Lahore, 54550
Country 65034 0
Pakistan
Phone 65034 0
+923024106463
Fax 65034 0
Email 65034 0
[email protected]
Contact person for public queries
Name 65035 0
Dr Sania Ahmad
Address 65035 0
Jinnah Burn & Reconstructive Surgery Center
Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road
Lahore, 54550
Country 65035 0
Pakistan
Phone 65035 0
+923024106463
Fax 65035 0
Email 65035 0
[email protected]
Contact person for scientific queries
Name 65036 0
Dr Sania Ahmad
Address 65036 0
Jinnah Burn & Reconstructive Surgery Center
Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road
Lahore, 54550
Country 65036 0
Pakistan
Phone 65036 0
+923024106463
Fax 65036 0
Email 65036 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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