Microneedling With Topical Preparations in the Treatment of Atrophic Post-acne Scars
Primary Purpose
Acne Scars - Mixed Atrophic and Hypertrophic
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
microneedling with topical glycolic acid 35%.
microneedling with topical human insulin solution.
Sponsored by
About this trial
This is an interventional treatment trial for Acne Scars - Mixed Atrophic and Hypertrophic
Eligibility Criteria
Inclusion Criteria: All types of facial atrophic acne scars Patients aged >18 years Both sexes Exclusion Criteria: Pregnancy and lactation Active acne or any active facial lesion History of keloid scar History of systemic diseases as DM or hypotension Bleeding and coagulation disorders Infection and immunosuppression
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Glycolic acid 35% group
topical insulin group
Arm Description
will be subjected to microneedling with topical glycolic acid 35%.
will be subjected to microneedling with topical human insulin solution.
Outcomes
Primary Outcome Measures
Goodman and Baron's acne scar grading system
Grade 1 Erythematous hypo or hyperpigmented flat marks Grade 2 Mild atrophy not obvious at social distance of >/=50 cm or easily covered by makeup or beard hair in male Grade 3 Moderate atrophy obvious at social distance of >/=50 cm, not easily covered by makeup or beard hair but able to be flattened by manual stretching of the skin Grade 4 Sever atrophy obvious at social distance >50 cm, not easily covered by makeup and not able to be flattened by manual stretching of skin
Quartile grading system
The improvement of patients is evaluated as follow:
Poor (improvement < 25%) Mild (improvement 26%-50%) Good (improvement 51%-75%) Excellent (improvement >75%)
5 point scale for evaluating patient's satisfaction
None (no satisfaction) Mild (1%-25% satisfaction) Moderate (26%-50% satisfaction) Good (51%-75% satisfaction) Very good (76%-100% satisfaction)
Pain assessment
Pain during the session will be assessed and graded as mild, moderat and sever (Saadawi et al., 2018).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05600075
Brief Title
Microneedling With Topical Preparations in the Treatment of Atrophic Post-acne Scars
Official Title
Microneedling With Topical Glycolic Acid 35% Versus Microneedling With Topical Insulin in the Treatment of Atrophic Post-acne Scars
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 22, 2023 (Anticipated)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To examine the anti-scarring effect of topical glycolic acid 35% combined with microneedling against that of topical insulin combined with microneedling for post acne scars
Detailed Description
Acne vulgaris (AV) is a common chronic inflammatory disease of skin that develops from sebaceous glands associated with hair follicles. Typically AV begins at puberty and may continue through adulthood affecting the comedogenic areas of face, back and chest .
One of the undesirable outcomes of acne is acne scars that are divided into two main types based on a loss (atrophic) or gain (hypertrophic) of collagen. Atrophic type is the most common type, further subdivided into three subtypes: icepick, boxcar and rolling scar .
Post acne scars occur in nearly 75% of patients with acne affecting both male and female equally . Acne scars impair quality of life and may be a risk factor for depression, suicide, low academic performance and unemployment .
There are different therapeutic modalities for atrophic acne scars including microneedling, chemical peeling, laser, filler, surgical procedures (punch excision, punch grafts) and fat transfer.
Microneedling is considered safe for all skin types. It is performed by dermapen or dermaroller to induce new collagen formation that remains for a few months after the procedure.
Microneedling enhances the effect of topical preparations when used combined with them due to increasing their absorption by creating small channels through the epidermis to the dermis .
It was reported that combination of glycolic acid (GA) with microneedling gave excellent results in treatment of post acne scars compared to microneedling alone.
Glycolic acid is an alpha hydroxy acid that decreases corneocytes cohesion leading to increasing keratinocytes turnover rate and faster desquamation .
It was found that glycolic acid increases dermal hyaluronic acid and collagen gene expression through increasing the secretion of IL6 .
the administration of topical human insulin was investigated for the treatment of atrophic post-acne scars and concluded that topical insulin following microneedling was associated with significant improvement.
Topical insulin induces collagen formation and neovascularization through synthesis of transforming growth factor (TGF b1) and vascular endothelial growth factor (VEGF).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Scars - Mixed Atrophic and Hypertrophic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Glycolic acid 35% group
Arm Type
Active Comparator
Arm Description
will be subjected to microneedling with topical glycolic acid 35%.
Arm Title
topical insulin group
Arm Type
Active Comparator
Arm Description
will be subjected to microneedling with topical human insulin solution.
Intervention Type
Drug
Intervention Name(s)
microneedling with topical glycolic acid 35%.
Intervention Description
15 patients will be subjected to microneedling with topical glycolic acid 35%. Selected patients will receive one session of microneedling combined with a topical agent, with two weeks interval till complete clearance or up to 6 sessions.
Intervention Type
Drug
Intervention Name(s)
microneedling with topical human insulin solution.
Intervention Description
15 patients will be subjected to microneedling with topical human insulin solution. Selected patients will receive one session of microneedling combined with a topical agent, with two weeks interval till complete clearance or up to 6 sessions.
Primary Outcome Measure Information:
Title
Goodman and Baron's acne scar grading system
Description
Grade 1 Erythematous hypo or hyperpigmented flat marks Grade 2 Mild atrophy not obvious at social distance of >/=50 cm or easily covered by makeup or beard hair in male Grade 3 Moderate atrophy obvious at social distance of >/=50 cm, not easily covered by makeup or beard hair but able to be flattened by manual stretching of the skin Grade 4 Sever atrophy obvious at social distance >50 cm, not easily covered by makeup and not able to be flattened by manual stretching of skin
Time Frame
through study completion, an average of 1 year
Title
Quartile grading system
Description
The improvement of patients is evaluated as follow:
Poor (improvement < 25%) Mild (improvement 26%-50%) Good (improvement 51%-75%) Excellent (improvement >75%)
Time Frame
through study completion, an average of 1 year
Title
5 point scale for evaluating patient's satisfaction
Description
None (no satisfaction) Mild (1%-25% satisfaction) Moderate (26%-50% satisfaction) Good (51%-75% satisfaction) Very good (76%-100% satisfaction)
Time Frame
through study completion, an average of 1 year
Title
Pain assessment
Description
Pain during the session will be assessed and graded as mild, moderat and sever (Saadawi et al., 2018).
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All types of facial atrophic acne scars
Patients aged >18 years
Both sexes
Exclusion Criteria:
Pregnancy and lactation
Active acne or any active facial lesion
History of keloid scar
History of systemic diseases as DM or hypotension
Bleeding and coagulation disorders
Infection and immunosuppression
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Microneedling With Topical Preparations in the Treatment of Atrophic Post-acne Scars
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