Melasma
Conditions
Keywords
facial epidermal melasma, MASI, Cysteamine 5%
Brief summary
This interventional, randomized, investigator blinded, controlled study conducted in one centre consists in a 4-month evaluation period within the same season avoiding sunny season on 140 subjects with facial epidermal melasma.
Detailed description
Melasma is a very common pigmentation disorder which significantly alters quality of life as per its high visibility on the face. The objective is to compare the efficacy and tolerability of the new depigmenting formulation that addresses the different targets of hyperpigmentation and includes an inhibitor of melanin production with a breakthrough innovative mechanism of action versus Cysteamine 5% in the acute management of melasma over 4 months. Statistics: Sample size calculation: 120 patients (60 per group) are necessary to reach the non-inferiority objective of the Test Product versus Cysteamine 5% on the modified Melasma Area and Severity Index (mMASI) change from Baseline at Month 4. To allow a rate of subjects excluded from analysis (drop out, lost to follow-up, major deviation) at Month 4, 140 subjects in total (70 per group) are enrolled. Statistical analysis: Continuous data collected at each visit will be summarized using common statistical measures such as the count of values, mean, standard deviation, median minimum and maximum. For categorical data, summaries will be provided in terms of frequency counts (n) and percentages (%).
Interventions
OTHERGroup TP
Application full face, twice daily, in the morning and at bedtime for 4 months
DRUGGroup CYS
Application short contact, of thin layer once daily at bedtime for 4 months
Sponsors
Cosmetique Active International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Facial epidermal melasma (exclude mixed and dermal melasma) * Subjects free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face
Exclusion criteria
* Subjects with any other signs of significant irritation or skin disease * Subjects using oral contraceptive pills or hormonal implants as birth control measures during the study * Subjects who had a skin lightening procedure in the past 8 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in mMASI scoring | from baseline to Day112 | the mMASI is calculated using 3 components: four regions of the face (forehead, right malar, left malar and chin); area of involvement for each region (using a scale from 0 to 6): darkness compared to the surrounding normal skin for each area (evaluated using a scale from 0 to 4). |
| change in Investigator's Global Assessment (IGA) | from baseline to Day112 | The investigator evaluates the severity of melasma using a 4-point scale (from 0 (cleared, almost cleared) to 3 (severe (markedly darker than the surrounding normal skin)). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in Subject Global Assessment of Improvement (SGAI) | from Day28 to Day112 | The subject evaluates the change on a 6-point scale from -1 (worsened) to 4 (totally cleared). |
Countries
India
Contacts
Primary ContactMukta Sachdev
Outcome results
None listed