TerminatedPhase 3ACTRN12619000406101

Treatment of Melasma with Cysteamine cream compared to Hydroquinone cream

Evaluation of the efficacy of cysteamine cream compared to hydroquinone cream in the treatment of melasma: a randomised, double-blind, multi-centre trial.

Sponsor

Dr Michelle Rodrigues

Enrollment

80 participants

Start Date

May 4, 2019

Study Type

Interventional

Conditions

Melasma

Summary

Melasma is a common disorder of hyperpigmentation, manifesting as slowly-expanding tan-brown macules, primarily affecting the face. This study is a randomised, double-blind efficacy study of cysteamine cream compared to hydroquinone cream. Participants will be asked to come for study visits at weeks 0, 8, and 16. At weeks 2 and 4, participants will receive a phone call to assess for any adverse side effects. At the baseline visit, each participant will be randomised into one of two arms. Participants will apply the drug to which they have been randomised daily and use a supplied sunscreen to the entire face during the day. Efficacy of the treatments will be measured by clinical examination of the face including modified Melasma Area Severity Index, digital photographs and the MelasQOL (quality of life) questionnaire. Adverse events will be monitored at each study visit and phone call.

Eligibility

Sex: FemalesMin Age: 18 Yearss

Inclusion Criteria7

Must provide informed consent
Must be over the age of 18 and female
Moderate to severe melasma defined by the following at screening visit:
a. Modified MASI scoring
Melasma present for at least 3 months
Willing and able to comply with study instructions and return to the study site for required visits
Must be able to comply with the study regimen for the duration of the study.

Exclusion Criteria7

Pregnant or breastfeeding
Rashes on the face
Job which is primarily outdoors (more than 2 hours per day) or goes to tanning salons
Hydroquinone, or other bleaching agents, used within the last month
Topical steroid applied to the face within the last month
Retin A, retinol, tretinoin, Differin, or adapalene used within the last month
Laser treatment to the face within the last month

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Interventions

Participants will be randomised in a 1:1 ratio to apply either Cysteamine cream or Hydroquinone cream. Arm 1 (intervention) - Participants to apply a thin layer of Cysteamine 5% cream in the evenin

Participants will be randomised in a 1:1 ratio to apply either Cysteamine cream or Hydroquinone cream. Arm 1 (intervention) - Participants to apply a thin layer of Cysteamine 5% cream in the evening to the affected areas of a clean face (washed with water or a gentle cleanser). After 15 minutes, the cream should be washed off, and the placebo cream applied to the affected areas and left on overnight. The Cysteamine tube is labelled 'apply first' and the placebo tube is labelled 'apply second' to maintain the double-blind nature of the trial. Compliance will be assessed by questioning the participant at week 2 and 4 phone calls and at study visits week 8 and 16. It is likely that a single 50g tube will last the participant 16 weeks, however if participants need an additional tube of study drug they will need to return the empty study drug tube to receive a second tube. Participants will be instructed to apply a standardised broad spectrum SPF 50+ sunscreen evenly and generously to the face 20 minutes prior to sun exposure. It is water resistant for 40 minutes and should be reapplied immediately after 40 minutes of swimming or sweating, otherwise reapplied 2-hourly during sun-exposure.