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

NCT05600075 | Unknown

• 1 other identifier: atrophic post-acne scars
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Acne Scars - Mixed Atrophic and Hypertrophic

Outcome Measures

Primary Outcomes (4)

• 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

  through study completion, an average of 1 year

• 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%)

  through study completion, an average of 1 year

• 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)

  through study completion, an average of 1 year

• Pain assessment

  Pain during the session will be assessed and graded as mild, moderat and sever (Saadawi et al., 2018).

  through study completion, an average of 1 year

Study Arms (2)

Glycolic acid 35% group

ACTIVE COMPARATOR

will be subjected to microneedling with topical glycolic acid 35%.

Drug: microneedling with topical glycolic acid 35%.

topical insulin group

ACTIVE COMPARATOR

will be subjected to microneedling with topical human insulin solution.

Drug: microneedling with topical human insulin solution.

Interventions

microneedling with topical glycolic acid 35%. DRUG

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.

Glycolic acid 35% group

microneedling with topical human insulin solution. DRUG

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.

topical insulin group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All types of facial atrophic acne scars
• Patients aged \>18 years
• Both sexes

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead

MeSH Terms

Conditions

Hypertrophy

Interventions

Percutaneous Collagen Induction

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 31, 2022
• Study Start: February 22, 2023
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02