Microneedling With Topical Preparations in the Treatment of Atrophic Post-acne Scars

• ClinicalTrials.gov Identifier: NCT05600075
• Recruitment Status: Not yet recruiting
• First Posted: October 31, 2022
• Last Update Posted: February 21, 2023
• Sponsor: Zagazig University
• Information provided by (Responsible Party): Norhan Anees, Zagazig University

Tracking Information

• First Submitted Date: October 21, 2022
• First Posted Date: October 31, 2022
• Last Update Posted Date: February 21, 2023
• Estimated Study Start Date: February 22, 2023
• Estimated Primary Completion Date: September 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 25, 2022)

• Goodman and Baron's acne scar grading system [ Time Frame: through study completion, an average of 1 year ]
  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 [ Time Frame: through study completion, an average of 1 year ]
  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 [ Time Frame: through study completion, an average of 1 year ]
  None (no satisfaction) Mild (1%-25% satisfaction) Moderate (26%-50% satisfaction) Good (51%-75% satisfaction) Very good (76%-100% satisfaction)
• Pain assessment [ Time Frame: through study completion, an average of 1 year ]
  Pain during the session will be assessed and graded as mild, moderat and sever (Saadawi et al., 2018).

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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).

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Acne Scars - Mixed Atrophic and Hypertrophic

Intervention

• Drug: microneedling with topical glycolic acid 35%.
  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.
• Drug: microneedling with topical human insulin solution.
  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.

Study Arms

• Active Comparator: Glycolic acid 35% group
  will be subjected to microneedling with topical glycolic acid 35%.
  Intervention: Drug: microneedling with topical glycolic acid 35%.
• Active Comparator: topical insulin group
  will be subjected to microneedling with topical human insulin solution.
  Intervention: Drug: microneedling with topical human insulin solution.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: October 25, 2022): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 1, 2023
• Estimated Primary Completion Date: September 1, 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT05600075
• Other Study ID Numbers: atrophic post-acne scars
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Norhan Anees, Zagazig University
• Original Responsible Party: Same as current
• Current Study Sponsor: Zagazig University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Zagazig University
• Verification Date: February 2023