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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
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Scars - Mixed Atrophic and Hypertrophic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. All types of facial atrophic acne scars
  2. Patients aged >18 years
  3. Both sexes

Exclusion Criteria:

  1. Pregnancy and lactation
  2. Active acne or any active facial lesion
  3. History of keloid scar
  4. History of systemic diseases as DM or hypotension
  5. Bleeding and coagulation disorders
  6. 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

    First Posted
    October 21, 2022
    Last Updated
    February 17, 2023
    Sponsor
    Zagazig University
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    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

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    Topical Timolol 0.5% in Atrophic Acne Scar

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