Split-face Study Comparing the Cosmetic Efficacy and Tolerability of Two Topical Products in Participants With Moderate Facial Melasma

NCT02977507 | Completed Results FDA Drug

• 1 other identifier: SKM16-LYT-MEL
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the efficacy and tolerability of Lytera 2.0 versus 4% hydroquinone in the improvement of the appearance of moderate facial melasma.

Conditions

Melasma

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Melasma Severity Rating Scale Score to Week 12

  The investigator assessed the participant's facial skin for the severity of symmetrical facial melasma on the left and the right side of the face using the Melasma Severity Rating Scale. The score ranges from 0 to 3, where 0=Cleared: color of melasma lesions approximately equivalent to surrounding normal skin or with minimal residual hyperpigmentation, 1=Mild: color slightly darker than the surrounding normal skin, 2=Moderate: color moderately darker than the surrounding normal skin and 3=Severe: color markedly darker than the surrounding normal skin. A negative change from Baseline indicates improvement.

  Baseline (Day 1) to Week 12

• Change From Baseline in Overall Hyperpigmentation Scale Score to Week 12

  The investigator assessed the participant's left and right facial sides for overall hyperpigmentation using the Overall Hyperpigmentation ten-point scale ranging from 0 to 9, where Score 0=None, skin is normal in color with no evidence of hyperpigmentation; Score 1, 2 or 3=Mild, several brown spots with increased pigmentation, they are small in size and slightly darker than surrounding skin; Score 4, 5 or 6=Moderate, many brown spots with increased pigmentation, they are medium in size and much darker than surrounding skin; Score of 7, 8 or 9=Severe, many large brown spots with increased pigmentation, they are large in size and markedly darker than surrounding skin. A negative change from Baseline indicates improvement.

  Baseline (Day 1) to Week 12

• Change From Baseline in Melasma Area and Severity Index (MASI) Score to Week 12

  The investigator assigned a grade for the left and right facial sides for each of the following: A=Total Area Involved (0=No involvement to 6=90 to 100% involvement); D=Darkness of Pigment (0=Normal skin color to 4=Severe hyperpigmentation); and H=Homogeneity (0=Normal skin color without evidence of hyperpigmentation to 4=Uniform skin involvement without any clear areas). Total Half-Face MASI score was calculated as: Half Forehead 0.15(D+H)A + One Malar Side 0.3 (D+H)A + Half Chin 0.05(D+H)A. A negative change from Baseline indicates improvement.

  Baseline (Day1) to Week 12

Secondary Outcomes (6)

• Number of Participants by Responses for Self-Assessment Questionnaire: Overall Improvement in Skin Condition

  Baseline (Day 1) to Weeks 4, 8 and 12

• Number of Participants by Responses for Self-Assessment Questionnaire: Overall Satisfaction With the Test Product

  Weeks 4, 8 and 12

• Number of Participants by Responses for Self-Assessment Questionnaire: Test Product Preference

  Weeks 4, 8 and 12

• Change From Baseline in Melasma Quality of Life (MELASQOL) Scale Total Score to Week 12

  Baseline (Day 1) to Week 12

• Investigator's Global Improvement Assessment for Overall Hyperpigmentation Score to Week 12

  Week 12

Study Arms (2)

Lytera 2.0

EXPERIMENTAL

Lytera 2.0 applied to the affected areas (dark patches) on one side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.

Other: Lytera 2.0; Other: SkinMedica Facial Cleanser; Other: SkinMedica Rejuvenative Moisturizer; Other: SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen

4% Hydroquinone Topical Cream

ACTIVE COMPARATOR

4% hydroquinone topical prescription cream applied to the affected areas (dark patches) on the other side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.

Drug: 4% Hydroquinone Topical Cream; Other: SkinMedica Facial Cleanser; Other: SkinMedica Rejuvenative Moisturizer; Other: SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen

Interventions

Lytera 2.0 OTHER

Lytera 2.0 applied to the affected areas twice a day, in the morning and evening, every day for 12 weeks.

Lytera 2.0

4% Hydroquinone Topical Cream DRUG

4% Hydroquinone Topical Cream applied to the affected areas twice a day, in the morning and evening, every day for 12 weeks.

4% Hydroquinone Topical Cream

SkinMedica Facial Cleanser OTHER

SkinMedica facial cleanser applied to the face as directed.

4% Hydroquinone Topical Cream; Lytera 2.0

SkinMedica Rejuvenative Moisturizer OTHER

SkinMedica rejuvenative moisturizer applied to the face as directed.

4% Hydroquinone Topical Cream; Lytera 2.0

SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen OTHER

SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 sunscreen applied to the face as directed.

4% Hydroquinone Topical Cream; Lytera 2.0

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male aged 18+ years with general good health
• Individuals with dark patches on both sides of their face
• Individuals that are willing to provide written informed consent and are able to read, speak, write, and understand English.
• Individuals willing to sign have their photographs taken during the study and are willing to sign a photography release.
• Willing to stop all facial treatments during the course of the study including botulinum toxin, injectable fillers, microdermabrasion, Intense pulsed light (IPL), peels, facials, waxing, laser treatments and tightening treatments. Threading is allowed but not facial laser hair removal.
• Willingness to cooperate follow all study requirements for the duration of the study and to report any changes in health status or medications, adverse event symptoms, or reactions immediately.
• Willingness to not begin using any new cosmetic facial make-up during the study. If you regularly use cosmetic facial make-up, you must have used the product(s) without any issues for at least 2 weeks prior to starting the study.
• Willingness to avoid sun exposure to the face as much as possible, (including tanning beds), especially from 10 AM to 2 PM. Protective clothing (i.e. hats) and the provided sunscreen should be worn prior to and during any exposure.

You may not qualify if:

• Individuals diagnosed with known allergies to study provided skin care products.
• Individuals who are nursing, pregnant, or planning to become pregnant during the study according to subject self-report.
• Individuals with a history of skin cancer.
• Individuals having a health condition on the face (e.g., psoriasis, rosacea, acne, eczema, seborrheic dermatitis, severe excoriations etc.).
• Individuals with a history of immunosuppression/immune deficiency disorders (including (Human immunodeficiency virus (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS)) or currently using immunosuppressive medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara.) and/or radiation.
• Individuals with an uncontrolled disease such as asthma, diabetes, hypertension, hyperthyroidism, or hypothyroidism. Individuals having multiple health conditions may be excluded from participation even if the conditions are controlled by diet, medication, etc.
• Individuals with any planned surgeries and/or invasive medical procedures during the course of the study.
• Individuals who have observable suntan, scars, nevi, excessive hair, etc. or other dermal conditions on the face that might influence the test results in the opinion of the Investigator or designee.
• Individuals who started hormone replacement therapies (HRT) or hormones for birth control less than 3 months prior to study entry or who plan on starting, stopping, or changing doses of HRT or hormones for birth control during the study.
• Individuals who used any of the following medications or had any of the listed procedures within the listed time frame prior to the study start date:
• Retin-A®, Retin-A Micro®, Renova®, Avita®, Tazorac®, or Differin® within 3 months
• Had a light-depth chemical peel or microdermabrasion within 1 month
• Had a medium-depth chemical peel, medium-depth microdermabrasion, any systemic steroids, non-ablative laser, light and/or radio frequency or fractional laser resurfacing of the face and neck within 3 months
• Any systemic retinoid (e.g. Soriatane®, Accutane®, Roche Dermatologics) within 12 months
• Any topical or systemic antibiotics, such as minocycline, or any other known medications that can cause photosensitivity, such as hydrochlorothiazide, lasix, amiodarone, within 1 month

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Mount Sinai St. Luke's Hospital

New York, New York, 10025, 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: Therapeutic Area, Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Elizabeth Makino

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: November 30, 2016
• Study Start: December 13, 2016
• Primary Completion: October 9, 2017
• Study Completion: October 9, 2017
• Last Updated: December 19, 2018
• Results First Posted: November 7, 2018

Record last verified: 2018-11

Locations

US (1)