Topical Timolol 0.5% in Atrophic Acne Scar

• ClinicalTrials.gov Identifier: NCT05597813
• Recruitment Status: Not yet recruiting
• First Posted: October 28, 2022
• Last Update Posted: February 21, 2023
• Sponsor: Zagazig University
• Information provided by (Responsible Party): Norhan Anees, Zagazig University

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.

Condition or disease	Intervention/treatment	Phase
Acne Scars - Mixed Atrophic and Hypertrophic	Procedure: microneedling; Procedure: microneedling with topical timolol 0.5%	Not Applicable

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 (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: The Role of Topical Timolol 0.5% in Wound Healing and Scar Improvement Following Atrophic Acne Scar Microneedling
• Estimated Study Start Date: March 1, 2023
• Estimated Primary Completion Date: October 1, 2023
• Estimated Study Completion Date: November 1, 2023

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Group A; microneedling group	Procedure: microneedling; 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.
Active Comparator: Group B; microneedling plus timolol group	Procedure: 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.

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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)

3. 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)
4. 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Norhan Anees, Principal Investigator, Zagazig University
• ClinicalTrials.gov Identifier: NCT05597813
• Other Study ID Numbers: atrophic acne scars
• First Posted: October 28, 2022
• Last Update Posted: February 21, 2023
• Last Verified: February 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Atrophy; Pathological Conditions, Anatomical; Timolol; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Antihypertensive Agents