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Clinical Trials/NCT05597813
NCT05597813
Not yet recruiting
Not Applicable

The Role of Topical Timolol 0.5% in Wound Healing and Scar Improvement Following Atrophic Acne Scar Microneedling

Zagazig University0 sites30 target enrollmentStarted: March 1, 2023Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
30
Primary Endpoint
Quartile grading system

Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • All types of facial atrophic acne scars
  • Patients aged \>18 years

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

Outcomes

Primary Outcomes

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)

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

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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Norhan Anees

Principal Investigator

Zagazig University

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