Acne Scars - Mixed Atrophic and HypertrophicNCT05600075
Microneedling With Topical Preparations in the Treatment of Atrophic Post-acne Scars
A study testing microneedling with topical glycolic acid 35%. and microneedling with topical human insulin solution. in people with Acne Scars - Mixed Atrophic and Hypertrophic, run by Zagazig University.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acne Scars - Mixed Atrophic and Hypertrophic
- What is being tested?
- microneedling with topical glycolic acid 35%. and microneedling with topical human insulin solution.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 22 Feb 2023to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All types of facial atrophic acne scars
- Patients aged >18 years
- Both sexes
Who cannot join
- 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
About this study
Official title: Microneedling With Topical Glycolic Acid 35% Versus Microneedling With Topical Insulin in the Treatment of Atrophic Post-acne Scars
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
Read the 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).
- Being tested
- microneedling with topical glycolic acid 35%., microneedling with topical human insulin solution.
- Medical subject headings
- Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Glycolic acid 35% group | Active comparator | will be subjected to microneedling with topical glycolic acid 35%. Receives: Drug: microneedling with topical glycolic acid 35%. |
| topical insulin group | Active comparator | will be subjected to microneedling with topical human insulin solution. Receives: Drug: microneedling with topical human insulin solution. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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%)
Measured: 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)
Measured: 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).
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start22 Feb 2023 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne Scars - Mixed Atrophic and HypertrophicStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Norhan Anees, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600075
- Sponsor's protocol ID
- atrophic post-acne scars
- Status last verified
- Feb 2023
- First submitted
- 21 Oct 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microneedling With Topical Glycolic Acid 35% Versus Microneedling With Topical Insulin in the Treatment of Atrophic Post-acne Scars
- ClinicalTrials.gov ID
- NCT05600075
- Acronym / sponsor ID
- atrophic post-acne scars
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 22 Feb 2023 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glycolic acid 35% group | Active comparator | Drug: microneedling with topical glycolic acid 35%.will be subjected to microneedling with topical glycolic acid 35%. |
| topical insulin group | Active comparator | Drug: microneedling with topical human insulin solution.will be subjected to microneedling with topical human insulin solution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All types of facial atrophic acne scars
- Patients aged >18 years
- Both sexes
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Glycolic acid 35% group |
| 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. | Drug | topical insulin group |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing microneedling with topical glycolic acid 35%. and microneedling with topical human insulin solution. in people with Acne Scars - Mixed Atrophic and Hypertrophic, run by Zagazig University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goodman and Baron's acne scar grading system (time frame: through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.