Polidocanol 1% and Steroid in Keloids and Hypertrophic Scars

Efficacy and Safety of Intralesional Injection of Polidocanol 1% in Treatment of Keloids and Hypertrophic Scars

we will inject intralesional polidocanol 1% in keloids and hypertrophic scars to decrease vascularity and decrease size of lesion compared to intralesional steroid as standard treatment line

Study Overview

• Status: Not yet recruiting
• Conditions: Keloid and Hypertrophic Scars
• Intervention / Treatment: Drug: Group 1 (polidocanol 1% group):; Drug: Group 2 (Triamcinolone acetonide group):; Drug: Group 3 (combined Triamcinolone acetonide and polidocanol 1% group):

Detailed Description

Patients and Methods

Ethical considerations:

This study will be submitted for approval by the Research Ethics Committee at Faculty of Medicine, Sohag University. Informed written consent will be taken from all participants.

Sample size:

Mean Vancouver Scar Scale (VSS) at the end of the follow up period will be considered the primary outcome of the study. We adopted 0.05alpha and 0.8 power values. With expected VSS mean values of 5, 4 and 3 for steroid, sclerotherapy and combined therapy, respectively, and pooled standard deviation value of 2, the anticipated sample size is expected to be 21 cases per group. We plan to recruit 30 cases per group to account for any dropouts.

Randomization:

Allocation of participants will be done with closed envelope, divided into three groups each one include (30) patients, Group (I) will be treated with polidocanol 1%, Group (II) will be treated with intralesional triamcinolone acetonide and Group (III) will be treated with combined intralesional triamcinolone acetonide and polidocanol 1%.

Study design:

Prospective randomized study, single blinded.

Study set up:

Out patient clinics of Dermatology, Venereology and Andrology, Sohag University Hospitals.

Methods

All patients in this study will be subjected to the following :

I- History:

1. Personal history: Age, sex, marital status, residence, occupation, education and special habits.
2. History of the present illness: Site, onset, course, duration, precipitating factors, previous treatment.
3. Past history: Similar condition, previous infection, trauma, skin piercing, surgical operation, acne.
4. Family history: Similar condition. II- General examination: To exclude any systemic diseases.

III- Keloid or HTSs evaluation:

1. Clinical assessment: The size, color, texture and height of the scar will be evaluated.

2. Photographic assessement:

   Photos will be taken using an iPhone13 pro max triple camera system (12-MP wide, ultra wide, telephoto cameras).

3. Dermoscopic assessment:

   Will be done by Iboolo de 3100 hand held dermoscope, polarized and non-polarized mode

4. Detroit keloid score
5. Vancouver Scar Scale include
6. Dermatology Life Quality Index (DLQI):
7. Ultrasound assessment

IV- Procedures:

1. The injection site will be prepared using alcohol 70%.
2. Topical anesthetic cream composed of lidocaine 2.5% and prilocaine 2.5% will be used with occlusion for 30- 45 minutes before injection.
3. The active substance will be injected intralesionally every 2 weeks for maximum 6 sessions or complete flattening of the lesion.

Group 1 (polidocanol 1% group):

Patients will receive polidocanol 1 %, a maximum of one milliliter of polidocanol 1% will be injected in each lesion using an insulin syringe with a 24-gauge needle.

Group 2 (Triamcinolone acetonide group):

Triamcinolone acetonide will be intralesionally injected at concentration of 20 mg/ml, a maximum of one-milliliter triamcinolone will be injected in the lesion.

Group 3 (combined injection of polidocanol 1% and Triamcinolone acetonide group):

The lesion will be injected 0.1ml/ cm2 Triamcinolone acetonide and 0.1 ml/cm2 polidocanol 1 %, with maximum 1ml Triamcinolone acetonide and 1 ml polidocanol 1 %.

V- Post procedure assessment:

1. Photographic assessment: Photos will be taken before each session and 3 months after the last session. The photos will be reviewed blindly by two expert dermatologists to determine the degree of improvement.
2. Dermoscopic assessment: the dermoscopic features will be recorded baseline, at the end of the sessions and 3 months after last session. The dermoscopic photos will be reviewed blindly by two expert dermatologists to determine the degree of improvement.
3. Detroit keloid scoring: will be recorded baseline, at the end of the sessions and 3 months after last session.
4. Vancouver Scar Scale: will be recorded baseline, at the end of the sessions and 3 months after last session.
5. Dermatology Life Quality Index (DLQI): will be recorded baseline, at the end of the sessions and 3 months after last session.
6. Ultrasound assessment : will be recorded at baseline, at the end of the sessions and 3 months after the last session.
7. Patient satisfaction: The level of patient's satisfaction will be measured using five-point Likert scale ((1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied) (47), at the end of the sessions and 3 months after last session.
8. Side effects: Any adverse effect of the procedures will be recorded. Statistical analysis

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: raghda mohamed hassan Raghda Mohamed Hassan, assistant lecturer; Phone Number: 01009683988; Email: raghdahmohammad@med.sohag.edu.eg

Study Locations

• Egypt
  • Sohag, Egypt
    • Sohag University
    • Contact: Raghda Mohammed Hassan Raghda Mohammed Hassan, assistant lecturer; Phone Number: 01009683988; Email: raghdhmohammad@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- Patients older than 16 years of both sex with keloids and/or hypertrophic scars ≤ year.

Exclusion Criteria:

1. Pregnancy, lactation.
2. Skin lesions, infection in the injection area.
3. Patients with systemic disease (diabetes mellitus, heart disease, cancer, mental illness).
4. Allergy to substances used.
5. Patients received treatment in previous 4 weeks.
6. Current anticoagulant therapy.
7. Active thromboembolic disease, use of oral contraceptives or other drugs affecting coagulation cascade.
8. History of venous or arterial thromboembolism.
9. Severe renal dysfunction.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1 (polidocanol 1% group): Patients will receive polidocanol 1 %, a maximum of one milliliter o	Drug: Group 1 (polidocanol 1% group): Patients will receive polidocanol 1 %, a maximum of one milliliter of polidocanol 1% will be injected in each lesion using an insulin syringe with a 24-gauge needle.3- The active substance will be injected intralesionally every 2 weeks for maximum 6 sessions or complete flattening of the lesion.
Active Comparator: Group 2 (Triamcinolone acetonide group): Triamcinolone acetonide will be intralesionally injected	Drug: Group 2 (Triamcinolone acetonide group): Triamcinolone acetonide will be intralesionally injected at concentration of 20 mg/ml, a maximum of one-milliliter triamcinolone will be injected in the lesion. 3- The active substance will be injected intralesionally every 2 weeks for maximum 6 sessions or complete flattening of the lesion.
Active Comparator: Group 3 ( combined Triamcinolone acetonide and polidocanol 1% group); The lesion will be injected 0.1ml/ cm2 Triamcinolone acetonide and 0.1 ml/cm2 polidocanol 1 %, with maximum 1ml Triamcinolone acetonide and 1 ml polidocanol 1 %.	Drug: Group 3 (combined Triamcinolone acetonide and polidocanol 1% group): The lesion will be injected 0.1ml/ cm2 Triamcinolone acetonide and 0.1 ml/cm2 polidocanol 1 %, with maximum 1ml Triamcinolone acetonide and 1 ml polidocanol 1 %.3- The active substance will be injected intralesionally every 2 weeks for maximum 6 sessions or complete flattening of the lesion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
improvment and flattening of keloids and hypertrophic scarsby improvement in a. Photographic assessment: Photos will be taken before each session and 3 months after the last session. The photos will be reviewed blindly by two expert dermatologists to d	baseline, at 12 week and 3 months after last session

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: May 13, 2026
• First Submitted That Met QC Criteria: May 18, 2026
• First Posted (Actual): May 26, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Connective Tissue Diseases; Cicatrix; Fibrosis; Collagen Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Cicatrix, Hypertrophic; Keloid; Organic Chemicals; Population Characteristics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Alcohols; Glycols; Demography; Ethylene Glycols; Polyethylene Glycols; Polidocanol; Population Groups
• Other Study ID Numbers: Soh-Med--26-5-3MD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No