Trial Outcomes & Findings for Topical Composition Therapy (2013-MCN-333) for the Treatment of Melasma (NCT NCT02730819)

Last Updated: 2017-10-20

Results Overview

Severity of melasma in each of the four regions (forehead, right malar region, left malar region and chin) is assessed on % of the total area involved (A), darkness (D), and homogeneity (H). Scoring for % area involved: 0=none; 1=\<10%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; and 6=90-100%. Darkness scoring (hyperpigmentation): 0=normal skin; 1=barely visible; 2=mild; 3=moderate; 4=severe. Homogeneity scoring: 0=normal skin color; 1=specks of involvement; 2=small patchy areas of involvement \<1.5 cm diameter; 3=patches of involvement \>2 cm diameter; 4=uniform skin involvement without any clear areas). To calculate the MASI score, the sum of the severity grade for darkness (D) and homogeneity (H) is multiplied by the numerical value of the areas (A) involved and by the percentages of the four facial areas (10-30%). Total MASI score: Forehead 0.3 (D+H)A + right malar 0.3 (D+H)A + left malar 0.3 (D+H)A + chin 0.1 (D+H)A. The total score can range from 0 (normal) to 48 (severe).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

Baseline, 20 weeks

Results posted on

2017-10-20

Participant Flow

Patients seen at the Mayo Clinic in Jacksonville, Florida between May 2016 and September 2016 were enrolled in the study.

Participant milestones

Participant milestones
Measure	Illuminate Cream Illuminate Cream is a skin-lightening formulation containing multiple drugs, including a retinoid, calcineurin inhibitor, anti-tyrosinase agent and sunscreen microfine zinc oxide. Approximately 0.5 grams to be applied topically to affected areas of skin once per day for 20 weeks.
Overall Study STARTED	19
Overall Study Follow-up Week 2	15
Overall Study Follow-up Week 4	16
Overall Study Follow-up Week 8	14
Overall Study Follow-up Week 12	11
Overall Study Follow-up Week 16	11
Overall Study Follow-up Week 20	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Illuminate Cream Illuminate Cream is a skin-lightening formulation containing multiple drugs, including a retinoid, calcineurin inhibitor, anti-tyrosinase agent and sunscreen microfine zinc oxide. Approximately 0.5 grams to be applied topically to affected areas of skin once per day for 20 weeks.
Overall Study Lost to Follow-up	9

Baseline Characteristics

Topical Composition Therapy (2013-MCN-333) for the Treatment of Melasma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Illuminate Cream n=16 Participants Illuminate Cream is a skin-lightening formulation containing multiple drugs, including a retinoid, calcineurin inhibitor, anti-tyrosinase agent and sunscreen microfine zinc oxide. Approximately 0.5 grams to be applied topically to affected areas of skin once per day for 20 weeks.
Age, Continuous	38 years n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants
Fitzpatrick Skin Type Type 1	0 Participants n=5 Participants
Fitzpatrick Skin Type Type 2	8 Participants n=5 Participants
Fitzpatrick Skin Type Type 3	5 Participants n=5 Participants
Fitzpatrick Skin Type Type 4	1 Participants n=5 Participants
Fitzpatrick Skin Type Type 5	2 Participants n=5 Participants
Use oral contraceptives	3 Participants n=5 Participants
Use sunscreen daily	11 Participants n=5 Participants
Melasma started with pregnancy	5 Participants n=5 Participants
Received prior treatments for melasma	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 20 weeks

Population: 19 participants were enrolled, but 9 participants were lost to follow-up over the course of the study.

Outcome measures

Outcome measures
Measure	Illuminate Cream n=10 Participants Illuminate Cream is a skin-lightening formulation containing multiple drugs, including a retinoid, calcineurin inhibitor, anti-tyrosinase agent and sunscreen microfine zinc oxide. Approximately 0.5 grams to be applied topically to affected areas of skin once per day for 20 weeks.
Change in Melasma Area and Severity Index (MASI) Score	-11.4 units on a scale Interval -15.3 to -3.6

SECONDARY outcome

Timeframe: baseline, 20 weeks

Population: 19 participants were enrolled, but 9 participants were lost to follow-up over the course of the study.

The Melasma Quality of Life Scale has 10 items, with responses ranging from 0 (no response) to 7 (bothered all the time. The range of possible scores is 0-70, with a higher score indicating a worse melasma-related quality of life.

Outcome measures

Outcome measures
Measure	Illuminate Cream n=10 Participants Illuminate Cream is a skin-lightening formulation containing multiple drugs, including a retinoid, calcineurin inhibitor, anti-tyrosinase agent and sunscreen microfine zinc oxide. Approximately 0.5 grams to be applied topically to affected areas of skin once per day for 20 weeks.
Change in Melasma Quality of Life Scale (MELASQOL)	-10 units on a scale Interval -35.0 to -1.0

SECONDARY outcome

Timeframe: baseline, 20 weeks

Population: 19 participants were enrolled, but 9 participants were lost to follow-up over the course of the study.

The investigator compared the extent of melasma at 20 weeks to a full-face photograph obtained in a standardized manner at baseline. It is a dynamic 7-point scale (0=completely clear to 7=worse).

Outcome measures

Outcome measures
Measure	Illuminate Cream n=10 Participants Illuminate Cream is a skin-lightening formulation containing multiple drugs, including a retinoid, calcineurin inhibitor, anti-tyrosinase agent and sunscreen microfine zinc oxide. Approximately 0.5 grams to be applied topically to affected areas of skin once per day for 20 weeks.
Investigator Assessment of Global Improvement From Baseline 0=Completely clear	0 Participants
Investigator Assessment of Global Improvement From Baseline 1=Almost clear	1 Participants
Investigator Assessment of Global Improvement From Baseline 2=Significant or marked improvement	2 Participants
Investigator Assessment of Global Improvement From Baseline 3=Moderate improvement	4 Participants
Investigator Assessment of Global Improvement From Baseline 4=Slight improvement	3 Participants
Investigator Assessment of Global Improvement From Baseline 5=No change from baseline	0 Participants
Investigator Assessment of Global Improvement From Baseline 6=Worse	0 Participants

Adverse Events

Illuminate Cream

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Illuminate Cream n=16 participants at risk Illuminate Cream is a skin-lightening formulation containing multiple drugs, including a retinoid, calcineurin inhibitor, anti-tyrosinase agent and sunscreen microfine zinc oxide. Approximately 0.5 grams to be applied topically to affected areas of skin once per day for 20 weeks.
Injury, poisoning and procedural complications Fell and broke ribs	6.2% 1/16 • Number of events 1 • 20 weeks
Skin and subcutaneous tissue disorders Peeling of skin	6.2% 1/16 • Number of events 1 • 20 weeks
Skin and subcutaneous tissue disorders Rash	6.2% 1/16 • Number of events 1 • 20 weeks
Skin and subcutaneous tissue disorders Itching	6.2% 1/16 • Number of events 1 • 20 weeks
Skin and subcutaneous tissue disorders Irritation on face due to sun exposure	6.2% 1/16 • Number of events 1 • 20 weeks
Skin and subcutaneous tissue disorders Erythema	100.0% 16/16 • Number of events 20 • 20 weeks
Skin and subcutaneous tissue disorders Scaling	100.0% 16/16 • Number of events 30 • 20 weeks
Skin and subcutaneous tissue disorders Dryness	100.0% 16/16 • Number of events 40 • 20 weeks
Skin and subcutaneous tissue disorders Stinging	100.0% 16/16 • Number of events 26 • 20 weeks

Additional Information

Dr. Jason Sluzevich

Mayo Clinic

Phone: 904-953-9453

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place