Microneedling With Topical Preparations in the Treatment of Atrophic Post-acne Scars
- Conditions
- Acne Scars - Mixed Atrophic and Hypertrophic
- Interventions
- Drug: microneedling with topical glycolic acid 35%.Drug: microneedling with topical human insulin solution.
- Registration Number
- NCT05600075
- Lead Sponsor
- Zagazig University
- 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).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- All types of facial atrophic acne scars
- Patients aged >18 years
- Both sexes
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Glycolic acid 35% group microneedling with topical glycolic acid 35%. will be subjected to microneedling with topical glycolic acid 35%. topical insulin group microneedling with topical human insulin solution. will be subjected to microneedling with topical human insulin solution.
- Primary Outcome Measures
Name Time Method Quartile grading system 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%)Goodman and Baron's acne scar grading system 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
5 point scale for evaluating patient's satisfaction 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 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).
- Secondary Outcome Measures
Name Time Method