An interventional study of Group 1 (polidocanol 1% group): and Group 2 (Triamcinolone acetonide group): in Keloid and Hypertrophic Scars, sponsored by Sohag University. Not yet recruiting at 1 site in Egypt. Open to participants aged 16 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by Sohag University · Not applicable, Interventional, and Treatment
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
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:
III- Keloid or HTSs evaluation:
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
IV- Procedures:
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:
138 studies on the registry are indexed under Keloid; 26 are open to participants now.
This study's planned enrollment of 90 is above the median of 30 across 109 interventional studies indexed under Keloid.
Browse Keloid studies →Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.
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- Patients older than 16 years of both sex with keloids and/or hypertrophic scars ≤ year.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Group 1 (polidocanol 1% group):
Drug: Group 2 (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 %.
Drug: Group 3 (combined Triamcinolone acetonide and 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.
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.
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.
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
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Aug 2026, 0 months later.
Of 20 interventional studies with no phase under Keloid, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 0 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Polidocanol · Triamcinolone Acetonide