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Reducing Hyperpigmentation After Sclerotherapy

Reducing Hyperpigmentation After Sclerotherapy (RHyAS) study: a multicenter, randomized, clinical trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN39680155
Enrollment
600
Registered
2020-04-20
Start date
2018-01-01
Completion date
Unknown
Last updated
2021-01-05

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

Conditions

Hyperpigmentation following sclerotherapy for varicose veins Skin and Connective Tissue Diseases Hyperpigmentation following sclerotherapy for varicose veins

Interventions

Participants who were included with telangiectasia, reticular or varicose veins who were candidates for sclerotherapy. They received Sclerotherapy using polidocanol 1% as sclerosant agent, 10ml maximu

Sponsors

CLINEDEM
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years 2. Telangiectatic, reticular, or varicose veins in lower limbs 3. Candidate for sclerotherapy 4. BMI 20 to 40 kg/m2 5. Fitzpatrick skin tone I – V 6. Signed consent to participate

Exclusion criteria

Exclusion criteria: 1. Acute thrombosis 2. History of deep vein thrombosis 3. Deep vein reflux 4. Saphenous vein reflux 5. Pregnancy 6. Bed confinement 7. Long term use of steroidal or nonsteroidal anti-inflammatory drugs (such as corticoids, methotrexate, etc.) 8. Severe leg edema

Design outcomes

Primary

MeasureTime frame
1. Incidence of post sclerotherapy hyperpigmentation measured using computer software at baseline, 1 and 3 months 2. Total area of hyperpigmentation measured using computer software at baseline, 1 and 3 months

Secondary

MeasureTime frame
1. Presence of major bleeding measured using computer software at baseline, 1 and 3 months 2. Clinical response of vein disappearance measured using computer software at baseline, 1 and 3 months

Countries

Mexico

Outcome results

None listed

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