Home interventions and light therapy for the treatment of vitiligo

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2015
INTERVENTION: Participants will be asked to treat their vitiligo patches at home for a period of 9 months. Participants will be allocated to three groups: 1. NB‐UVB light therapy (Dermfix Model 1000MX) plus placebo ointment (white soft paraffin) 2. Placebo NB‐UVB light therapy (Dermfix 1000MX with no NB‐UVB output) plus potent topical corticosteroid ointment (Mometasone Furoate 0.1% [Elocon]) 3. NB‐UVB light therapy (Dermfix Model 1000MX) plus potent topical corticosteroid ointment (Mometasone Furoate 0.1% [Elocon]) CONDITION: Vitiligo ; Skin and Connective Tissue Diseases ; Vitiligo PRIMARY OUTCOME: Patient‐reported treatment success based on vitiligo noticeability scale at target lesion; Timepoint(s): 9 months SECONDARY OUTCOME: 1. Adverse events and adverse device effects; Timepoint(s): 3, 6, 9 months; 2. Cost‐effectiveness; Timepoint(s): 21 months; 3. Investigator assessed onset of treatment response (including cessation of spread); Timepoint(s): 3, 6, 9 months; 4. Investigator assessed percentage of repigmentation; Timepoint(s): 3, 6, 9 months; 5. Reassessed by digital image at 9 months; 6. Patient reported Maintenance of Repigmentation (3 lesions); Timepoint(s): 12, 15, 18 ,21 months; 7. Patient reported treatment success based on vitiligo noticeability scale at three body sites; Timepoint(s): 3, 6, 9 months; 8. Quality of Life measures; Timepoint(s): 9 and 21 months INCLUSION CRITERIA: 1. Patients 5 years of age or over with a diagnosis of non‐segmental vitiligo confirmed by a dermatologist 2. Vitiligo limited to less than 10% of body surface area, with at least one patch that is reported by the participant to have been active (new onset or spread) in the last 12 months 3. No other active therapy for vitiligo (or willing to stop current treatment – no washout period required) 4. Able to administer the intervention safely at home 5. Able and willing to give informed consent (or parental/guardian consent in the case of children)
Epistemonikos ID: 58816b50d5bf463b33b3976b34845af38a3759b3
First added on: Oct 16, 2021