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

NCT02730819 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 15-005615
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to gather information on the effectiveness and tolerability of a novel composition of existing U.S. Food and Drug Administration (FDA) approved topical medications for the treatment of moderate to severe melasma.

Conditions

Melasma

Outcome Measures

Primary Outcomes (1)

• Change in Melasma Area and Severity Index (MASI) Score

  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).

  Baseline, 20 weeks

Secondary Outcomes (2)

• Change in Melasma Quality of Life Scale (MELASQOL)

  baseline, 20 weeks

• Investigator Assessment of Global Improvement From Baseline

  baseline, 20 weeks

Study Arms (1)

Illuminate Cream

EXPERIMENTAL

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.

Drug: Illuminate Cream

Interventions

Illuminate Cream DRUG

Topical compound applied daily

Also known as: 2013-MCN-333

Illuminate Cream

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients 18 to 65 years age
• Moderate to severe melasma, as measured by the Melasma Area Severity Index score greater than or equal to 16
• No prior use of topical skin-lightening agents for 1 month prior to study entry
• Good general health as confirmed by medical history
• Female patients of child-bearing potential with a negative urine pregnancy test who agree to use effective methods of birth control or remain abstinent during treatment. Participants must use birth control for the entire study and for at least 1 week after the last application of the study formulation. Acceptable methods of birth control include ongoing hormonal contraception methods, (such as birth control pills, patches, injections, vaginal ring, or implants), barrier methods (such as a condom or diaphragm used with a spermicide), intrauterine devices, tubal ligation, or abstinence
• Patients who are willing and capable of cooperating to the extent and degree required by the protocol; and
• Patients who read and sign an approved informed consent for this study

You may not qualify if:

• Vulnerable study population
• Exposure to topical skin-lightening agents within 1 month of study entry, including:
• Topical corticosteroids
• Topical bleaching products
• Topical retinoids
• Use of systemic preparations within 1 month of study entry, including:
• Systemic corticosteroids
• Systemic cyclosporine, interferon
• Systemic acitretin, etretinate, isotretinoin
• Systemic methotrexate
• Systemic photoallergic, phototoxic and/or photosensitizing drugs
• UV light therapy and sunbathing
• Inability to communicate or cooperate with the Principal Investigator and/or Investigators due to language problems, poor mental development or impaired cerebral function
• Pregnant or nursing women
• Women planning a pregnancy within the study period

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Jason Sluzevich
• Organization: Mayo Clinic

Sluzevich.Jason@mayo.edu

904-953-9453

Study Officials

• Jason C Sluzevich, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Dermatology

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 7, 2016
• Study Start: May 15, 2016
• Primary Completion: December 30, 2016
• Study Completion: December 30, 2016
• Last Updated: October 20, 2017
• Results First Posted: September 20, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)