Clinical trial NCT02977507: Split-face Study Comparing the Cosmetic Efficacy and Tolerability of Two Topical Products in Participants With Moderate Facial Melasma
Official title: Randomized, Double-blinded, Split-face Study Comparing the Cosmetic Efficacy and Tolerability of Two Topical Products in Subjects With Moderate Facial Melasma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melasma
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2016-11-30
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 are currently participating in any other facial usage study or have participated in any clinical trial within 4 weeks prior to inclusion into 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
  * Any topical tretinoin product or derivative, imiquimod, 5-fluorouracil, or diclofenac on their face within 3 months
  * Prescription strength skin lightening products (e.g. 4% hydroquinone, tretinoin, alpha hydroxy acid (AHA), beta hydroxy acid (BHA) and polyhydroxy acids, 15% or 20% azelaic acid, 4-hydroxyanisole alone or in combination with tretinoin, etc.) within 3 months
  * Any non-prescription cosmetic anti-wrinkle, skin lightening products, or any other product or topical or systemic medication known to affect skin aging or dyshcromia (products containing alpha/beta/poly-hydroxy acids, vitamin C, soy, Q-10, hydroquinone; systemic or licorice extract (topically), Tego® Cosmo C250, gigawhite, lemon juice extract (topically), emblica extract, etc.) within 2 weeks
  * Have undergone plastic surgery, Dermabrasion (deep skin peel), a deep chemical peel or ablative laser resurfacing of the face and neck within 12 months
  * Had facial treatment with a botulinum toxin base injectable (Botox), injectable fillers, or a fat transfer within 6 months

Primary outcomes:
measure: Change From Baseline in Melasma Severity Rating Scale Score to Week 12
timeFrame: Baseline (Day 1) to Week 12
measure: Change From Baseline in Overall Hyperpigmentation Scale Score to Week 12
timeFrame: Baseline (Day 1) to Week 12
measure: Change From Baseline in Melasma Area and Severity Index (MASI) Score to Week 12
timeFrame: Baseline (Day1) to Week 12
Secondary outcomes:
measure: Number of Participants by Responses for Self-Assessment Questionnaire: Overall Improvement in Skin Condition
timeFrame: Baseline (Day 1) to Weeks 4, 8 and 12
measure: Number of Participants by Responses for Self-Assessment Questionnaire: Overall Satisfaction With the Test Product
timeFrame: Weeks 4, 8 and 12
measure: Number of Participants by Responses for Self-Assessment Questionnaire: Test Product Preference
timeFrame: Weeks 4, 8 and 12
measure: Change From Baseline in Melasma Quality of Life (MELASQOL) Scale Total Score to Week 12
timeFrame: Baseline (Day 1) to Week 12
measure: Investigator's Global Improvement Assessment for Overall Hyperpigmentation Score to Week 12
timeFrame: Week 12
measure: Change From Baseline in Mexameter Measurement of Target Hyperpigmentation Lesion to Week 12
timeFrame: Baseline (Day 1) to Week 12
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai St. Luke's Hospital
state: New York
Study officials:
affiliation: Allergan
name: Elizabeth Makino
role: STUDY_DIRECTOR
References: