To evaluate and compare the efficacy of 5% cysteamine cream and 4% hydroquinone cream in reducing melasma severity
Design
Study Design: Double-blind, Randomized Controlled trial
Study Setting: Combined Military Hospital,Quetta
Study Duration: 6 months
Sample Size: The sample size for this study was calculated using the WHO calculator and following parameters :-
Level of significance (α) :5 %
Power of the test (1-β) :90 %
Anticipated Population Proportion 1 (P1): 0.249
Anticipated Population Proportion 1(P2): 0.38 9
Sample size (n): 228
Sampling Technique:
Non probability consecutive sampling
Settings and conduct
Combined Military Hospital Quetta
Participants in cysteamine group will be instructed to apply a pea-sized amount of the assigned cream to the affected areas once daily at night as per following procedure :-
15 minutes for 1st 15 days.
Subsequently, add 1 minute in 15 minutes everyday till 30th day.
Continue to apply cream for 30 minutes for next 2 months.
Participants in the hydroquinone group will apply thin layer over night for next 3 months.
Patients will be assessed after every month for melasma according to MASI score.Picture will be captured at each visit for visual documentation and analysis.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: mild to moderate melasma (MASI score 4-24).
Patients with epidermal and dermal hyperpigmentation.
Patients with Fitzpatrick skin types III to V .
Exclusion Criteria:Lactating and pregnant mother
Chronic underlying skin condition
Patient allergic to cysteamine and hydroquinone
Intervention groups
Melasma: An acquired pigmentary disorder characterized by hyperpigmented patches on sun-exposed areas of the skin.
MASI Score: A validated measure used to quantify the severity of melasma, based on the area, darkness, and homogeneity of pigmentation.
Main outcome variables
Change in MASI score from baseline
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210823052264N13
Registration date:2025-01-09, 1403/10/20
Registration timing:registered_while_recruiting
Last update:2025-01-09, 1403/10/20
Update count:0
Registration date
2025-01-09, 1403/10/20
Registrant information
Name
Najia Ahmed
Name of organization / entity
PNS shifa
Country
Pakistan
Phone
+92 81 2864092
Email address
najiaomer@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-01, 1403/10/12
Expected recruitment end date
2025-06-01, 1404/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of 5% cysteamine vs 4% hydroquinone in melasma
Public title
Efficacy of 5% cysteamine vs 4% hydroquinone in melasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adults aged 18-50 years with a clinical diagnosis of mild to moderate melasma (MASI score 4-24).
Patients with Fitzpatrick skin types III to V .
Patients with epidermal and dermal hyperpigmentation.
Patients willing to use sun protection and adhere to treatment protocols.
Exclusion criteria:
Patients with chronic underlying diseases like eczema
Pregnant and breastfeeding
Patients allergic to cysteamine and hydroquinone
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
228
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomisation by lottery method Participants in cysteamine group will be instructed to apply a pea-sized amount of the assigned cream to the affected areas once daily at night as per following procedure :-
15 minutes for 1st 15 days.
Subsequently, add 1 minute in 15 minutes everyday till 30th day.
Continue to apply cream for 30 minutes for next 2 months.
Participants in the hydroquinone group will apply thin layer over night for next 3 months.
Patients will be assessed after every month for melasma according to MASI score.Picture will be captured at each visit for visual documentation and analysis.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blinded study. Participant and data analyzer are blinded.