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Studies

Interventional Not yet recruiting Phase 1/Phase 2

NCT05893108 on ClinicalTrials.gov

Ethosomal Gel Bearing Losartan 5% for Keloid Treatment

Official title: The Effect of Ethosomal Gel Bearing Losartan 5% on The Patient and Observer Scar Assessment Scale Score, Degree of Erythema and Pigmentation, Surface Area, Thickness and Pliability of Human Keloids

  • Sponsor: Yuni Eka Anggraini
  • Collaborators: Gadjah Mada University
  • Enrollment: 46 (Estimated)
  • Study start: 2024-03-30 (Estimated)
  • Primary completion: 2024-09-30 (Estimated)
  • Study completion: 2024-10-30 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Two groups received different treatment at the same time. Both outcomes were measured at the same time before and after treatment with 4 measurements.
  • Masking: Single (Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief Summary

The objectives are to compare the efficacy of pre and post-treatment and between 5% losartan potassium loaded in ethosomal gel and 10 mg/ml triamcinolone acetonide injection based on the indicator score of The patient and observer scar assessment scale 3.0 (POSAS 3.0), degree of erythema and pigmentation, area size, thickness and density of human keloids.

Conditions

  • Keloid

Intervention / Treatment

  • Drug: Ethosomal gel bearing losartan 5%
  • Drug: triamcinolone acetonide 10 mg/ml

Primary Outcome Measures

  • The patient and observer scar assessment scale score (POSAS 3.0) (change from baseline the POSAS score at 4,8, and 12 weeks, consecutively.)
    The Patient and Observer Scar Assessment Scale 3.0 consists of sixteen items of the patient questionnaire (PSAS) with maximum and minimum values are 80 and 16, consecutively; and seven items of the observer questionnaire (OSAS) with maximum and minimum values are 35 and 7, consecutively. The lower score, the better result of the keloid.

Countries

Indonesia

Locations and Investigators

  • Rumah Sakit Syafira, Pekanbaru, Indonesia
    • Yuni Eka Anggraini
    • Yuni Anggriaini (Principal Investigator)
    • Niken Trisnowati
    • Ronny Martien
    • Retno Danarti