View clinical trials related to Vitiligo.
Filter by:Vitiligo is a relatively common acquired chronic disorder of pigmentation characterized by the development of white macules on the skin due to loss of epidermal melanocytes .Affecting approximately 0.5%-2% of general population worldwide, without predilection for sex or race.
The aim of this study is to establish whether the use of a special digital camera (SIAscopy) can provide an accurate and reliable measure of vitiligo which is at least equivalent to the current gold standard of planimetry. If so, SIAscopy could be used as an objective diagnostic and prognostic tool in the management of vitiligo patients within dermatology departments and allow a fair and accurate assessment of new potential treatments.
Vitiligo is a common acquired disorder of pigmentation affecting 0.5% to 1% of the world population. Sharply demarcated patches of depigmentation, which can affect all ethnicities, and can lead to cosmetic disfiguration and psychosocial distress, characterize the disease. The etiology of vitiligo remains unknown. Various mechanisms have been proposed, such as autoimmunity, self-destruction, biochemical, genetic, neural, oxidative stress, and an imbalance of epidermal cytokines leading to inflammation and selective loss of epidermal melanocytes. Currently, the most popular theory is autoimmunity. Previous studies noted that around 25-30% of patients have at least one other autoimmune disease, such as autoimmune thyroid disease, Addison's disease, pernicious anemia, and alopecia areata. Currently, NB-UVB phototherapy is the most widely used therapeutic option for vitiligo affecting more than 10-20% of the skin surface, as it is generally considered to be a safe initial treatment. Potential side effects include phototoxic reaction, thickening of the skin and koebnerization. NB-UVB is a band of UV radiation with a wavelength of 311-313 nm. UVB induces mitogenesis and migration in melanocytes mediated by several factors such as IL-1, TNF alpha, and leukotriene C4. UV radiation produces increased number and activity of melanocytes, increased melanin density, elongation and branching of dendrites, with increased transfer of more heavily melanized melanosomes to keratinocytes, seen clinically as increased pigmentation. Apremilast is an oral small molecule phosphodiesterase-4 (PDE4) inhibitor that has been shown to regulate inflammatory mediators. Apremilast enters cells by passive diffusion and, once intracellular, binds PDE4. PDE-4, the dominant phosphodiesterase expressed in immune cells, degrades cyclic AMP (cAMP) into AMP. PDE4 inhibition thereby elevates intracellular cAMP, which can down-regulate the inflammatory responses such as TNF-α, IFN-γ, interleukins (IL) 2, 12 and 23 through mechanisms such as partially inhibiting expression of inflammatory cytokines and increasing expression of anti-inflammatory mediators such as IL2 and IL10. The hypothesis is that apremilast will shut down the inflammatory insult in vitiligo and NB-UVB phototherapy will then be able to regenerate melanocytes and their activity. By examination of skin biopsies taken pre- and post-therapy, the study team aims to assess changes in immune and cellular markers in affected skin.
The purpose of this study will be to examine the efficacy, safety, and tolerability of ruxolitinib cream in subjects with vitiligo.
OBJECTIVE: To investigate the efficacy of the cyclic on-off treatment compared to the conventional continuous excimer laser treatment. DESIGN: A randomized, controlled, split-body, non-inferiority study. SETTING: The trial was performed in two tertiary health care centers in Korea. PARTICIPANT: Twelve patients (16 pairs of lesions) with stable symmetric vitiligo less than 5 years' disease duration were enrolled. INTERVENSION: The paired symmetric vitiliginous lesions were randomized to either the continuous or the cyclic on-off treatment. All lesions were treated twice weekly for 9-month: continuously, or cyclically with 2-month treatment and 1-month intermission (total 3 cycles). Topical tacrolimus was applied throughout the trial. OUTCOME MEASURES: The repigmentation was assessed using an image analysis program with clinical photographs. The primary outcome was mean difference of repigmentation rates and the non-inferiority margin was set at 10%. During intermission period, the clinical changes such as loss of repigmentation or worsening of the vitiligo lesions were assessed.
Vitiligo is a depigmentation disorder affecting 0.5 to 2% of the general population. It is an acquired pigmentary disorder of the skin and mucous membranes that is characterized by circumscribed, depigmented macules and patches. Apremilast is a phosphosdiesterase 4 (PDE4) inhibitor that showed efficacy and very good tolerance in rheumatoid arthritis and psoriasis. Apremilast induces a potent activation of the cyclic AMP (cAMP) pathway leading to anti-inflammatory effect by decreasing the response of Th1 and Th17 lymphocytes. Interestingly, the cAMP pathway is also well demonstrated to be the main pathway for promoting melanogenesis and for inducing the differentiation and the proliferation of melanocytes. The principal aims is to compare, after 24 weeks of treatment, the efficacy of Apremilast at the label dosage in combination therapy with narrow band UVB versus placebo therapy with narrow band UVB for repigmentation in patients with non-segmental vitiligo. Patients with non-segmental vitiligo with BSA > 10% and patient with Vitiligo stable or slowly progressive for 3 months , seeking for treatment in the Department of Dermatology, University Hospital of Nice, France will be recruited into the study. The Patients are seen in consultation by the investigator, selection criteria are checked. All patients will receive full body narrow UVB treatment, twice weekly sessions of narrow UVB for 24 weeks. From W24 to W48 - All responders* will receive narrow UVB treatment according the French clinical use i.e.twice weekly sessions of narrowband UVB for 24 weeks. - All responders* will be randomized to receive either apremilast** 30mg BID or placebo. - Response is defined as an increase of at least 30 % in the VASI score at W24 compare to baseline **Responders initially randomized in the placebo arm will benefit of the titration At week 24, the non responders patients will stop the treatment and the study after the 4 weeks observationnal follow-up (W28). Observational Follow-up Phase - W48 to W52 Four-week Observational Follow-up Phase for all subjects who complete the study (responders and non responders) or discontinue the study early.
Rationale: Autologous epidermal cell suspension grafting is an effective method of surgical treatment in vitiligo, which is suitable for treating large areas with good cosmetic results. The RenovaCell Autologous Cell Harvesting Device (Avita Medical Europe Limited, Cambridge, UK) (previous name: ReCell) is a device which, compared to other forms of autologous epidermal cell suspension grafting, is easier in use showing similar results. Efficacy and safety of the ReCell device was proven in segmental vitiligo and piebaldism. However, the efficacy in non-segmental vitiligo is not yet confirmed in randomized controlled trials. The investigators hypothesize that grafting using the ReNovaCell device in combination with standard of care is also effective in stable non-segmental vitiligo and more effective than standard of care alone. Objective: Primary: to assess the efficacy and safety of ReNovaCell grafting combined with 311 nm UVB therapy and topical anti-inflammatory therapy for the treatment of stable non-segmental vitiligo. Secondary: to assess, satisfaction, cosmetic acceptability, noticeability and persistence of repigmentation after ReNovaCell transplantation. Study design: Prospective, observer-blinded, randomised, within subject, controlled, study. Study population: 20 patients ≥ 18 years with stable non-segmental vitiligo receiving standard of care (311 nm UVB therapy and topical anti-inflammatory therapy) for at least 6 months at the Netherlands Institute for Pigment Disorders (NIPD) at the Academic Medical Centre, University of Amsterdam. Intervention: In patients already receiving standard of care (311 nm UVB therapy + topical anti-inflammatory therapy) 2 comparable depigmented regions are randomised to receive ReNovaCell grafting or no grafting. Standard of care will be given according to the standard treatment protocol of our institute. Main study parameters/endpoints: Primary outcome: Objective assessment of the degree of repigmentation three and six months after ReNovaCell grafting with a digital image analysis system. To assess the pigmentation, the contours of pigmentation are copied on a transparent sheet before, three and six months after treatment, after which the sheets are scanned and digital image analysis is used to compute the affected surface. By comparing pre- and post-treatment pictures, the relative surface showing repigmentation expressed as percentage of the selected treated patch is computed. Secondary outcomes: - Patient Reported Outcomes: satisfaction, cosmetic acceptability, noticeability - General patient assessed outcome per treatment region on a scale from 0-3 (poor, moderate, good or excellent). - Visual assessment of percentage repigmentation by blinded observer and color match to normal skin - Visual assessment of side effects per treatment region (hyperpigmentation, hypopigmentation and scarring on a scale from 0-3) by a blinded investigator. - A small amount of the suspension of the included patients and the redundant lesional punchgrafts of all patients will be used for flow cytometric analyses of the cellular composition of the grafted cell suspension, and expression analysis of melanin synthesis-related genes. These data will be correlated to the clinical data. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: As the study involves large depigmented lesions, which are too large to treat in regular surgical treatment (punch grafting), patients will not miss any regular treatment. The time investment for the patient will be approximately 20 minutes for the punchgrafting session, 75 minutes for the cell suspension grafting session and 15 minutes for the three follow-up visits. Two of the five visits are part of the standard of care UVB follow-up regimen and are therefore not additional due to the study. Infection in the grafted area or the donor site may occur but is very rare; the risk of mild textural changes in the donor site is moderate. Hyperpigmentation of the treated area does occur often, although this improves over time in most cases. In case of improvement of the depigmentation, patients may receive another treatment for the (contralateral) untreated side.
Vitiligo is a complex disease causing a selective, often progressive, loss of functioning melanocytes from epidermal basal layer resulting in white patches on the skin and occasionally mucosae. Worldwide prevalence of vitiligo is around 1% whereas in India it is around 3-4% ranging from 0.46% to 8.8%. Etiopathogenesis of vitiligo is multifactorial consisting of genetic, immunological and environmental factors. Environmental and genetic factors act in concert to destroy melanocytes. Reactive oxygen species (ROS) play important roles in vitiligo pathology,but the autoimmune pathogenesis has been proposed as one of the main causes of vitiligo. Surgical methods, mainly transplantation of non cultured epidermal cell suspension are effective treatment for stable vitiligo. Transplantation of autologous noncultured epidermal cell suspension and non-cultured dermal cell suspension in combination (a mode of cellular grafting technique) is a novel surgical method for the treatment of vitiligo. Cytotoxic CD8+ ( cluster of differentiation 8+) cells in vitiligo perilesions may dictate the fate of transplantation, and strategies against CD8+ T cell activation might be beneficial for patients undergoing melanocyte transplantation. Mesenchymal cells could inhibit T cell proliferation and induce T cell apoptosis. Bartsch first identified and characterized dermal mesenchymal cells (DMCs). They have a multi-lineage differentiation potential into adipocytes, osteocytes and chondrocytes.Vitiligo patients' autologous melanocytes transplantation efficiency may be predicted by perilesional skin-homing CD8+ T cell activities, and the immunoregulatory DMCs might be used as auxiliary agent to improve the efficacy. This pilot study is planned to compare transplantation of autologous noncultured epidermal cell suspension v/s its combination with non-cultured dermal cell suspension as a novel method in vitiligo surgery in stability of vitiligo with regards to extent of repigmentation, color matching of repigmented area, patient satisfaction and adverse events if any. This is the first study using transplantation of autologous noncultured epidermal cell suspension and non-cultured dermal cell suspension in combination as a new modality in vitiligo surgery.
Actually the methods for melanocyte delivery are invasive and often sophisticated. The dermarolling system with needles causing tiny microinjuries in the epidermis could offer a minimally invasive and painless method of melanocyte transplantation. The purpose of the study is to develop a new and simple method for transepidermally delivering keratinocytes and melanocytes into vitiligo skin.
A randomized controlled non-inferiority trial based on split-body was planned to compare the efficacy of 308-nm excimer laser and 311-nm Ti:Sapphire laser in patients with vitiligo.