Acne Scars - Mixed Atrophic and HypertrophicNCT05597813
Topical Timolol 0.5% in Atrophic Acne Scar
A study testing microneedling and microneedling with topical timolol 0.5% in people with Acne Scars - Mixed Atrophic and Hypertrophic, run by Zagazig University.
Trial summary
The aim of the study is to evaluate the efficacy and safety of microneedling combined with topical timolol 0.5% in the treatment of atrophic 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 and microneedling with topical timolol 0.5%
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to 1 Nov 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: The Role of Topical Timolol 0.5% in Wound Healing and Scar Improvement Following Atrophic Acne Scar Microneedling
The aim of the study is to evaluate the efficacy and safety of microneedling combined with topical timolol 0.5% in the treatment of atrophic 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 (Mazzetti et al., 2019).
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 (Bahl et al., 2020).
Post acne scars occur in nearly 75% of patients with acne affecting both male and female equally (Khunger and Kumar, 2012). Acne scars impair quality of life and may be a risk factor for depression, suicide, low academic performance and unemployment (Sood et al., 2020).
There are different therapeutic modalities for atrophic acne scars including microneedling, chemical peeling, laser, filler, surgical procedures (punch excision, punch grafts) and fat transfer (Pavlidis and Katsambus, 2017).
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 (Cohen and Elbuluk, 2016).
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 (Jaffe, 1981).
Ghassemi et al. (2021) observed that application of 0.5% timolol after TCA-CROSS caused a slight increase in scar improvement with more physician and patients' satisfaction.
Timolol, a beta-adrenergic receptor blocker, improves healing of skin wounds by increasing the phosphorylation of extracellular signal regulated kinases (ERK) leading to keratinocyte migration (Zeigler et al., 1999). Also, ERK initiate signaling cascades leading to fibroblast mitosis and proliferation with regulation of fibroblast functions in replacement of disorganized collagen and the reposition of the extracellular matrix (de Araújo et al., 2019).
- Being tested
- microneedling, microneedling with topical timolol 0.5%
- Medical subject headings
- Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microneedlingProcedure or surgery
15 patients will be subjected to microneedling alone. Selected patients will receive one session with two weeks interval till complete clearance or up to 6 sessions.
microneedling with topical timolol 0.5%Procedure or surgery
15 patients will be subjected to microneedling with topical timolol 0.5%.Selected patients will receive one session with two weeks interval till complete clearance or up to 6 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | microneedling group Receives: Procedure: microneedling |
| Group B | Active comparator | microneedling plus timolol group Receives: Procedure: microneedling with topical timolol 0.5% |
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 9 months
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%) (Saadawi et al., 2018)
Measured: through study completion, an average of 9 months
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) (El Domyati et al., 2015)
Measured: through study completion, an average of 9 months
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 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start1 Mar 2023 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Nov 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
- NCT05597813
- Sponsor's protocol ID
- atrophic 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
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
- The Role of Topical Timolol 0.5% in Wound Healing and Scar Improvement Following Atrophic Acne Scar Microneedling
- ClinicalTrials.gov ID
- NCT05597813
- Acronym / sponsor ID
- atrophic acne scars
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 28 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.
The aim of the study is to evaluate the efficacy and safety of microneedling combined with topical timolol 0.5% in the treatment of atrophic 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 (Mazzetti et al., 2019).
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 (Bahl et al., 2020).
Post acne scars occur in nearly 75% of patients with acne affecting both male and female equally (Khunger and Kumar, 2012). Acne scars impair quality of life and may be a risk factor for depression, suicide, low academic performance and unemployment (Sood et al., 2020).
There are different therapeutic modalities for atrophic acne scars including microneedling, chemical peeling, laser, filler, surgical procedures (punch excision, punch grafts) and fat transfer (Pavlidis and Katsambus, 2017).
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 (Cohen and Elbuluk, 2016).
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 (Jaffe, 1981).
Ghassemi et al. (2021) observed that application of 0.5% timolol after TCA-CROSS caused a slight increase in scar improvement with more physician and patients' satisfaction.
Timolol, a beta-adrenergic receptor blocker, improves healing of skin wounds by increasing the phosphorylation of extracellular signal regulated kinases (ERK) leading to keratinocyte migration (Zeigler et al., 1999). Also, ERK initiate signaling cascades leading to fibroblast mitosis and proliferation with regulation of fibroblast functions in replacement of disorganized collagen and the reposition of the extracellular matrix (de Araújo et al., 2019).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: microneedlingmicroneedling group |
| Group B | Active comparator | Procedure: microneedling with topical timolol 0.5%microneedling plus timolol group |
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 |
|---|---|---|
| microneedling15 patients will be subjected to microneedling alone. Selected patients will receive one session with two weeks interval till complete clearance or up to 6 sessions. | Procedure or surgery | Group A |
| microneedling with topical timolol 0.5%15 patients will be subjected to microneedling with topical timolol 0.5%.Selected patients will receive one session with two weeks interval till complete clearance or up to 6 sessions. | Procedure or surgery | Group B |
Primary outcome
Goodman and Baron's acne scar grading system
Time frame: through study completion, an average of 9 months
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 9 months
The improvement of patients is evaluated as follow: Poor (improvement < 25%) Mild (improvement 26%-50%) Good (improvement 51%-75%) Excellent (improvement >75%) (Saadawi et al., 2018)
5 point scale for evaluating patient's satisfaction
Time frame: through study completion, an average of 9 months
None (no satisfaction) Mild (1%-25% satisfaction) Moderate (26%-50% satisfaction) Good (51%-75% satisfaction) Very good (76%-100% satisfaction) (El Domyati et al., 2015)
Pain assessment
Time frame: through study completion, an average of 9 months
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.
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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 and microneedling with topical timolol 0.5% 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 9 months). 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.