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Comparison of the effect of carboxytherapy and fluocinolone acetonide ointment in the treatment of macular amyloidosis

Comparison of efficacy of carboxytherapy and topical fluocinolone acetonide 0.025% in treatment of macular amyloidosis

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240612062098N1
Enrollment
20
Registered
2024-09-07
Start date
2024-08-27
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular amyloidosis. Amyloidosis of skin

Interventions

Intervention 1: Intervention group: Carboxytherapy is injected subcutaneously with a 4mm long 30G mesotherapy needle at an angle of 15 degrees and with a distance of 1 cm in each area through the inje

Sponsors

Arak University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Age > 18 years and < 80 years The presence of macular amyloidosis lesions in the area between the shoulder blades, arms, thighs, or upper chest relatively similar on both sides

Exclusion criteria

Exclusion criteria: Prone to keloid formation Pregnancy and breastfeeding Smoking, alcohol and drug abuse History of any treatment to eliminate macular amyloidosis lesions from 6 weeks before the start of the study Taking drug therapy (also including food supplements) from 6 weeks before the start of the study Suffering from connective tissue diseases or Geno dermatosis Suffering from any systemic diseases such as diabetes, kidney diseases, heart diseases, respiratory diseases, liver diseases, severe anemia, etc. The presence of active skin infections in the area of ??carboxytherapy Presence of systemic amyloidosis

Design outcomes

Primary

MeasureTime frame
Pigmentation. Timepoint: Checking the level of pigmentation of the lesions at the beginning of the study (before the start of the intervention) and before each session of carboxytherapy (5 sessions with an interval of 2 weeks) and two weeks after the last session of carboxytherapy. Method of measurement: Pigmentation grading system(from 0 to 4).;Pigmentation pattern. Timepoint: Examination of the pigmentation pattern of the lesions in the form of presence or absence of a wavy pattern at the beginning of the study (before the start of the intervention) and before each session of carboxytherapy (5 sessions with an interval of 2 weeks) and two weeks after the last session of carboxytherapy. Method of measurement: The presence or absence of a wave pattern.;Pigmentation percentage. Timepoint: Checking the percentage of pigmentation of the lesions at the beginning of the study (before the start of the intervention) and before each session of carboxytherapy (5 sessions with an interval of 2 weeks) and two weeks after the last session of carboxytherapy. Method of measurement: Calculation relative to skin phototype from phototype III onwards based on the pigmentation percentage scoring system.;Skin thickness. Timepoint: Checking the thickness of the skin in the lesion area at the beginning of the study (before the start of the intervention) and before each carboxytherapy session (5 sessions with an interval of 2 weeks) and two weeks after the last carboxytherapy session. Method of measurement: Presence or absence of lichenification.;The amount of itching. Timepoint: Checking the amount of itching in the lesion area at the beginning of the study (before the start of the intervention) and before each session of carboxytherapy (5 sessions with an interval of 2 weeks) and two weeks after the last session of carboxytherapy. Method of measurement: They are scored from 0 (no itching) to 10 (severe itching).;Participants' satisfaction. Timepoint: Examining the level of satisfaction

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarzaneh Farokhi

Arak University of Medical Sciences

farzaneh.farokhi98@gmail.com+98 86 3417 3532

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026