Topical Timolol 0.5% in Atrophic Acne Scar
Primary Purpose
Acne Scars - Mixed Atrophic and Hypertrophic
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
microneedling
microneedling with topical timolol 0.5%
Sponsored by
About this trial
This is an interventional treatment trial for Acne Scars - Mixed Atrophic and Hypertrophic
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
microneedling group
microneedling plus timolol group
Outcomes
Primary Outcome Measures
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
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)
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)
Pain assessment
Pain during the session will be assessed and graded as mild, moderat and sever (Saadawi et al., 2018).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05597813
Brief Title
Topical Timolol 0.5% in Atrophic Acne Scar
Official Title
The Role of Topical Timolol 0.5% in Wound Healing and Scar Improvement Following Atrophic Acne Scar Microneedling
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Scars - Mixed Atrophic and Hypertrophic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
microneedling group
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
microneedling plus timolol group
Intervention Type
Procedure
Intervention Name(s)
microneedling
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
microneedling with topical timolol 0.5%
Intervention Description
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.
Primary Outcome Measure Information:
Title
Goodman and Baron's acne scar grading system
Description
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
Time Frame
through study completion, an average of 9 months
Title
Quartile grading system
Description
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)
Time Frame
through study completion, an average of 9 months
Title
5 point scale for evaluating patient's satisfaction
Description
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)
Time Frame
through study completion, an average of 9 months
Title
Pain assessment
Description
Pain during the session will be assessed and graded as mild, moderat and sever (Saadawi et al., 2018).
Time Frame
through study completion, an average of 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Learn more about this trial
Topical Timolol 0.5% in Atrophic Acne Scar
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