Polidocanol 1% and Steroid in Keloids and Hypertrophic Scars

NCT07606391 | Not Yet Recruiting

• 1 other identifier: Soh-Med--26-5-3MD
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Keloid and Hypertrophic Scars

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Group 1 (polidocanol 1% group): Patients will receive polidocanol 1 %, a maximum of one milliliter o

ACTIVE COMPARATOR

Drug: Group 1 (polidocanol 1% group):

Group 2 (Triamcinolone acetonide group): Triamcinolone acetonide will be intralesionally injected

ACTIVE COMPARATOR

Drug: Group 2 (Triamcinolone acetonide group):

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

ACTIVE COMPARATOR

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):

Interventions

Group 2 (Triamcinolone acetonide group): DRUG

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.

Group 2 (Triamcinolone acetonide group): Triamcinolone acetonide will be intralesionally injected

Group 1 (polidocanol 1% group): DRUG

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.

Group 1 (polidocanol 1% group): Patients will receive polidocanol 1 %, a maximum of one milliliter o

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

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.

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

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University

Sohag, Egypt

Location

MeSH Terms

Conditions

Keloid; Cicatrix, Hypertrophic

Interventions

Polidocanol; Population Groups

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Demography; Population Characteristics

Central Study Contacts

raghda mohamed hassan Raghda Mohamed Hassan, assistant lecturer

CONTACT

01009683988; raghdahmohammad@med.sohag.edu.eg

Study Design

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

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 26, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)