Topical Timolol 0.5% in Atrophic Acne Scar

NCT05597813 | Unknown

• 1 other identifier: atrophic acne scars
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acne Scars - Mixed Atrophic and Hypertrophic

Outcome Measures

Primary Outcomes (4)

• 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

  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)

  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)

  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).

  through study completion, an average of 9 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

microneedling group

Procedure: microneedling

Group B

ACTIVE COMPARATOR

microneedling plus timolol group

Procedure: microneedling with topical timolol 0.5%

Interventions

microneedling PROCEDURE

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.

Group A

microneedling with topical timolol 0.5% PROCEDURE

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.

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead

MeSH Terms

Conditions

Hypertrophy

Interventions

Percutaneous Collagen Induction

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 28, 2022
• Study Start: March 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02