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This study has as objectives:
Primary objective :
• Evaluate the percentage of repigmentation observed one month after the end of three months of treatment measured on an objective layer by image analysis;
Secondary objectives:
Evaluate:
Population:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lithium liposome and placebo A | Other | • Group A : 4 patients; Lithium liposome 1 application / day (evening) on target lesions on one side of the body, placebo 1 application / day (evening) on contralateral target lesions and excimer lamp on target lesions on the two sides; |
|
| Lithium liposome and placebo B | Other | Group B : 4 patients; Liposomal Lithium 2 applications / day (morning and evening) on target lesions on one side of the body, placebo 2 applications / day (morning and evening) on contralateral target lesions and excimer lamp on target lesions on the two sides; |
|
| Lithium liposome and placebo C | Other | Groupe C : 4 patients; Lithium liposome 2 applications / day (morning and evening) on one side, placebo 2 applications / day (morning and evening) on contralateral target lesions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lithium liposome | Other | Cosmetic product |
|
| Measure | Description | Time Frame |
|---|---|---|
| the percentage of repigmentation | • Evaluate the percentage of repigmentation observed one month after the end of three months of treatment measured on an objective layer by image analysis; | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| the percentage of repigmentation and acceptability | the percentage of repigmentation observed after one, two and three months of treatment measured on an objective layer by image analysis;
|
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•Inclusion Criteria: Sexe: female and male;
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samy FENNICHE | Hbib Thamer Hosptal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hbib thamer Hospital | Tunis | Tunisia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 25, 2019 | Oct 30, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Three parallel groups testing different dosages / combinations of treatments
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| Placebo | Other | Cosmetic product vehicle |
|
| 1 month, 2 months, 3 months |