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| Name | Class |
|---|---|
| Procitech | UNKNOWN |
| Sanofi | INDUSTRY |
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Treatment of facial lipoatrophy with dermal injections polylactic acid (Newfill TM) is a safe procedure and has been now widely used with a good efficacy. However, this therapy is not effective in all treated patients and the benefit of the injections may decrease with time necessitating re-injections several months after the first sets of injections. In this study we would like to compare the efficacy and safety of Eutrophill(polyacrylamid gel), a resorbable filler compound versus Newfill in a comparative, randomised, multicenter trial. Primary endpoint will be the self-perception by the patient with a visual analogue scale (VAS index). Secondary endpoints are a quality of life questionnaire (MOS-HIV), the a-NBC questionnaire (perception by the patient and by the doctor of the severity of the lipoatrophy), the measure of the dermal thickness and cheek skin fold as assessed by the Skinfold Caliper, the ordering of digital photographs and the evaluation of the dermal thickness by CT scan.
The aim of the study is to compare the efficacy and safety of Eutrophill (polyacrylamid gel), a resorbable filler compound versus Newfill( polylactic acid) in a comparative, randomised, multicenter trial and patient-blinded study, in the treatment of facial lipoatrophy in HIV-infected patients, one year after the first injection (week 48). The efficacy will be assessed by measuring the median self-perception index of the patients with a visual analogue scale (VAS index).The study will compare between treatments, at week 48, week 72 and week 96 versus baseline :the median increase of the VAS index, the rate of treatment failure, the scores of 2 patients-questionnaires (a-NBC and MOS-HIV),the ordering of digital photographs,the median increase of the facial dermal thickness of the cheek and the dermal skin fold as assessed by a Skinfold Caliper.
The study will compare at week 48 and week 96 versus baseline:
the median increase of dermal thickness as assessed by CT scan of the face. Safety will be assessed by the frequency and nature of immediate and delayed side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | newfill |
|
| 2 | Experimental | Eutrophill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Newfill | Device | 1 to 7 injections of drug |
| |
| Eutrophill |
| Measure | Description | Time Frame |
|---|---|---|
| - patient's subjective self-perception of improvement of facial lipoatrophy as assessed by a VAS | week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| quality of life questionnaire,NBC questionnaire, dermal thickness and cheek skin fold as assessed by the Skinfold Caliper, digital photographs, dermal thickness as assessed by CT scan | week 0, week 48 and week 96 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthieu Lafaurie, MD | Hopital Saint Louis AP-HP | Principal Investigator |
| Raphael Porcher, MD | Hôpital Saint-Louis AP-HP | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Saint-Louis Service des Maladies Infectieuses | Paris | 75010 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23432777 | Derived | Lafaurie M, Dolivo M, Girard PM, May T, Bouchaud O, Carbonnel E, Madelaine I, Loze B, Porcher R, Molina JM; ANRS 132 SMILE study group. Polylactic acid vs. polyacrylamide hydrogel for treatment of facial lipoatrophy: a randomized controlled trial [Agence Nationale de Recherches sur le SIDA et les Hepatites Virales (ANRS) 132 SMILE]. HIV Med. 2013 Aug;14(7):410-20. doi: 10.1111/hiv.12021. Epub 2013 Feb 24. |
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| Device |
1 to 7 injections of drug |
|
| ID | Term |
|---|---|
| D039682 | HIV-Associated Lipodystrophy Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D008060 | Lipodystrophy |
| D012875 | Skin Diseases, Metabolic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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