Reducing Hyperpigmentation After Sclerotherapy
| ISRCTN | ISRCTN39680155 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39680155 |
| Secondary identifying numbers | 8936-042019 |
- Submission date
- 03/04/2020
- Registration date
- 20/04/2020
- Last edited
- 11/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
Varicose veins are swollen blood vessels that are most commonly in the lower legs and feet. They may be dark blue or purple, and are often lumpy or twisted in appearance. People can experience swollen, itchy, aching and uncomfortable legs, feet and ankles. One treatment for varicose veins is called sclerotherapy, which involves an injection into the vein which causes the blood in the vein to clot and vein to collapse and shrink. One of the side effects of this treatment is that patients can be left with discolouration of the skin which can appear darker/hyperpigmented.
This study aims to find out if adding a drug called sulodexide to the standard sclerotherapy treatment for patients with varicose veins can reduce the presence of hyperpigmentation following the procedure without affecting the intended therapy of vein elimination or increasing the risk of major bleeding
Who can participate?
Patients who are aged 18 to 65 years with telangiectatic, reticular, or varicose veins in their lower limbs who are suitable candidates for sclerotherapy
What does the study involve?
Half of the participants will receive standard sclerotherapy treatment. The other half will receive sulodexide 7 days before the scheduled sclerotherapy. All participants will be advised to wear compression stockings for 7 days afterwards. At 1 and 3 months participants will return for follow up appointments to check for the success of the sclerotherapy and for hyperpigmentation.
What are the possible benefits and risks of participating?
Possible benefits of this treatment could be improved patient satisfaction, which is very important in a procedure mostly done for cosmetics reasons. Additionally, faster improvement in the emotional wellbeing and quality of life of the patient.
With the reduction of the incidence of post-sclerotherapy hyperpigmentation, the possibility to treat larger veins with sclerotherapy can be contemplated, and possibly avoid a more expensive procedure like surgical stripping; this can be important in the socioeconomic population where sclerotherapy is the only possible treatment.
Where is the study run from?
CLINEDEM, ISSSTECALI and Hospital General Issste 5 de Diciembre (Mexico)
When is the study starting and how long is it expected to run for?
From January 2018 to September 2019
Who is funding the study?
This study is investigator-initiated and funded
Who is the main contact?
Dr Alejandro Gonzalez Ochoa
2alex8as@gmail.com
Contact information
Scientific
Callejón 5 de Mayo and Calle 7 No. 791
Planta Alta
San Luis Rio Colorado
83449
Mexico
 ORCID ID |
0000-0001-5068-623X |
|---|---|
| Phone | +526538497372 |
| 2alex8as@gmail.com |
Study information
| Study design | Prospective, multicentric, randomized controlled trial, using a parallel-group design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Reducing Hyperpigmentation After Sclerotherapy (RHyAS) study: a multicenter, randomized, clinical trial. |
| Study acronym | RHyAS study |
| Study objectives | The use of sulodexide in patients with varicose vein treated with sclerotherapy can reduce the incidence of hyperpigmentation |
| Ethics approval(s) | Approved 21/11/2017, the Universidad Autónoma de Baja California (Coordination de Posgrado e Investigacion. av Alvaro Obregon y Julian Carrillo s/n Colonia Nueva cp 21100 Edificio de Rectoria, Mexicali Baja California, Mexico; +52 686 551 9497; anahernandez@uabcinvestigacion.net) |
| Health condition(s) or problem(s) studied | Hyperpigmentation following sclerotherapy for varicose veins |
| Intervention | 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 maximum dose per session, total of 2 sessions 6 weeks apart. 20-30mmhg compression stockings were used in both groups for 7 days. Participants were randomly assigned, in a 1:1 ratio, to either group A or group B. Group A received an oral dose (250 LSU) of sulodexide bid 7 days prior to scheduled sclerotherapy that continued for 3 months. Group B received the standard sclerotherapy protocol. Photographic control was taken, and follow-up was done at 1 and 3 months. With the aid of computer software, the treated area was compared for the variables of incidence of pigmentation, the total area of pigmentation, skin-tone increase in pigmented area, vein disappearance, and incidence of major bleeding. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Suldexide 250 LSU bid oral dose for 3 months Polidocanol 1% 10ml maximum dose per session |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 01/06/2017 |
| Completion date | 01/09/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 600 |
| Total final enrolment | 720 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2018 |
| Date of final enrolment | 01/08/2019 |
Locations
Countries of recruitment
- Mexico
Study participating centres
Callejón 5 de Mayo and Calle 7 No. 791
Planta Alta
San Luis Rio Colorado
83449
Mexico
Centro Civico
Mexicali
21000
Mexico
Centro Civico
Mexicali
21000
Mexico
Sponsor information
Hospital/treatment centre
Callejón 5 de Mayo and Calle 7 No. 791
Planta Alta
San Luis Rio Colorado
83449
Mexico
| Phone | +526535367497 |
|---|---|
| alex8as2@yahoo.com.mx | |
| Website | http://clinedem.com/ |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 17/06/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned application for a paper publication and meeting oral presentation |
| IPD sharing plan | The datasets generated and/or analyzed during the current study during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 18/05/2020 | No | No | ||
| Results article | results | 01/01/2021 | 11/12/2020 | Yes | No |
Additional files
- ISRCTN39680155_BasicResults.docx
- uploaded 18/05/2020
Editorial Notes
11/12/2020: Publication reference added.
18/05/2020: The basic results of this trial have been uploaded as an additional file.
20/04/2020: Trial’s existence confirmed by the International Union of Phlebology.
