Polidocanol 1% and Steroid in Keloids and Hypertrophic Scars

ConditionKeloid and Hypertrophic Scars

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age16-60

SponsorSohag University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Pregnancy, lactation.

Skin lesions, infection in the injection area.

Patients with systemic disease (diabetes mellitus, heart disease, cancer, mental illness).

Allergy to substances used.

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

90 Participants

are divided into 3 treatment groups

Group A: Group 1 (polidocanol 1% group): Patients will receive polidocanol 1 %, a maximum of one milliliter oActive comparator 1 intervention

Group B: Group 2 (Triamcinolone acetonide group): Triamcinolone acetonide will be intralesionally injectedActive comparator 1 intervention

Group C: Group 3 ( combined Triamcinolone acetonide and polidocanol 1% group)Active comparator 1 intervention

Trial outcomes

Primary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sohag University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: