Keloid and Hypertrophic ScarsNCT07606391
Polidocanol 1% and Steroid in Keloids and Hypertrophic Scars
A study testing Group 1 (polidocanol 1% group):, Group 2 (Triamcinolone acetonide group): and Group 3 (combined Triamcinolone acetonide and polidocanol 1% group): in people with Keloid and Hypertrophic Scars, run by Sohag University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Keloid and Hypertrophic Scars
- What is being tested?
- Group 1 (polidocanol 1% group):, Group 2 (Triamcinolone acetonide group): and Group 3 (combined Triamcinolone acetonide and polidocanol 1% group):
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2026to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients older than 16 years of both sex with keloids and/or hypertrophic scars ≤ year.
Who cannot join
- 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.
Show all 9Show fewer
- Active thromboembolic disease, use of oral contraceptives or other drugs affecting coagulation cascade.
- History of venous or arterial thromboembolism.
- Severe renal dysfunction.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
raghda mohamed hassan Raghda Mohamed Hassan, assistant lecturer contact
Egypt1 site
Sohag University
Sohag
Raghda Mohammed Hassan Raghda Mohammed Hassan, assistant lecturer, 01009683988, raghdhmohammad@med.sohag.edu.eg
About this study
Official title: 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
Read the 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:
- Personal history: Age, sex, marital status, residence, occupation, education and special habits.
- History of the present illness: Site, onset, course, duration, precipitating factors, previous treatment.
- Past history: Similar condition, previous infection, trauma, skin piercing, surgical operation, acne.
- Family history: Similar condition. II- General examination: To exclude any systemic diseases.
III- Keloid or HTSs evaluation:
- Clinical assessment: The size, color, texture and height of the scar will be evaluated.
- Photographic assessement: Photos will be taken using an iPhone13 pro max triple camera system (12-MP wide, ultra wide, telephoto cameras).
- Dermoscopic assessment: Will be done by Iboolo de 3100 hand held dermoscope, polarized and non-polarized mode
- Detroit keloid score
- Vancouver Scar Scale include
- Dermatology Life Quality Index (DLQI):
- Ultrasound assessment
IV- Procedures:
- The injection site will be prepared using alcohol 70%.
- Topical anesthetic cream composed of lidocaine 2.5% and prilocaine 2.5% will be used with occlusion for 30- 45 minutes before injection.
- 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:
- 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.
- 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.
- Detroit keloid scoring: will be recorded baseline, at the end of the sessions and 3 months after last session.
- Vancouver Scar Scale: will be recorded baseline, at the end of the sessions and 3 months after last session.
- Dermatology Life Quality Index (DLQI): will be recorded baseline, at the end of the sessions and 3 months after last session.
- Ultrasound assessment : will be recorded at baseline, at the end of the sessions and 3 months after the last session.
- 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.
- Side effects: Any adverse effect of the procedures will be recorded. Statistical analysis
- Conditions
- Keloid and Hypertrophic Scars
- Being tested
- Group 1 (polidocanol 1% group):, Group 2 (Triamcinolone acetonide group):, Group 3 (combined Triamcinolone acetonide and polidocanol 1% group):
- Medical subject headings
- Keloid, Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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 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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (polidocanol 1% group): Patients will receive polidocanol 1 %, a maximum of one milliliter o | Active comparator | Not described Receives: Drug: Group 1 (polidocanol 1% group): |
| Group 2 (Triamcinolone acetonide group): Triamcinolone acetonide will be intralesionally injected | Active comparator | Not described Receives: 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 %. Receives: Drug: Group 3 (combined Triamcinolone acetonide and polidocanol 1% group): |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, at 12 week and 3 months after last session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keloid and Hypertrophic ScarsStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raghda Mohamed Hassan, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07606391
- Sponsor's protocol ID
- Soh-Med--26-5-3MD
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Intralesional Injection of Polidocanol 1% in Treatment of Keloids and Hypertrophic Scars
- ClinicalTrials.gov ID
- NCT07606391
- Acronym / sponsor ID
- Soh-Med--26-5-3MD
- Conditions
- Keloid and Hypertrophic Scars
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- Personal history: Age, sex, marital status, residence, occupation, education and special habits.
- History of the present illness: Site, onset, course, duration, precipitating factors, previous treatment.
- Past history: Similar condition, previous infection, trauma, skin piercing, surgical operation, acne.
- Family history: Similar condition. II- General examination: To exclude any systemic diseases.
III- Keloid or HTSs evaluation:
- Clinical assessment: The size, color, texture and height of the scar will be evaluated.
- Photographic assessement: Photos will be taken using an iPhone13 pro max triple camera system (12-MP wide, ultra wide, telephoto cameras).
- Dermoscopic assessment: Will be done by Iboolo de 3100 hand held dermoscope, polarized and non-polarized mode
- Detroit keloid score
- Vancouver Scar Scale include
- Dermatology Life Quality Index (DLQI):
- Ultrasound assessment
IV- Procedures:
- The injection site will be prepared using alcohol 70%.
- Topical anesthetic cream composed of lidocaine 2.5% and prilocaine 2.5% will be used with occlusion for 30- 45 minutes before injection.
- 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:
- 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.
- 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.
- Detroit keloid scoring: will be recorded baseline, at the end of the sessions and 3 months after last session.
- Vancouver Scar Scale: will be recorded baseline, at the end of the sessions and 3 months after last session.
- Dermatology Life Quality Index (DLQI): will be recorded baseline, at the end of the sessions and 3 months after last session.
- Ultrasound assessment : will be recorded at baseline, at the end of the sessions and 3 months after the last session.
- 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.
- Side effects: Any adverse effect of the procedures will be recorded. Statistical analysis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | 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 %. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients older than 16 years of both sex with keloids and/or hypertrophic scars ≤ year.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Group 1 (polidocanol 1% group): Patients will receive polidocanol 1 %, a maximum of one milliliter o |
| 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. | Drug | Group 2 (Triamcinolone acetonide group): Triamcinolone acetonide will be intralesionally injected |
| 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. | Drug | Group 3 ( combined Triamcinolone acetonide and polidocanol 1% group) |
Primary outcome
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
Time frame: baseline, at 12 week and 3 months after last session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
raghda mohamed hassan Raghda Mohamed Hassan, assistant lecturer contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1 (polidocanol 1% group):, Group 2 (Triamcinolone acetonide group): and Group 3 (combined Triamcinolone acetonide and polidocanol 1% group): in people with Keloid and Hypertrophic Scars, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact raghda mohamed hassan Raghda Mohamed Hassan, assistant lecturer (01009683988, raghdahmohammad@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: baseline, at 12 week and 3 months after last session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.