Randomized Study Using SM-030 Gel for Adults With Melasma

Inclusion Criteria

Subjects must meet all of the following criteria to be included in the study:

1. Subjects must meet all of the following criteria to be included in the study:

2. Male or Female age 18-65 with Fitzpatrick skin type II through V and a clinicaldiagnosis of Melasma

3. Subjects with moderate to severe Melasma using the following guidelines:

4. Stable (unchanged per subject reporting) melasma for at least 3 months 2. Macularlesions, neither depressed nor atrophic 3. Melasma Severity Score of at least 2 (hyperpigmentation at least moderately darker than surrounding normal skin 3.Ability to understand, agree to, and sign the study informed consent form (ICF).

5. For female or childbearing subjects, they must be on an agreeable form of birthcontrol (oral contraceptive therapies, estrogen replacement therapies, othernon-oral hormonal therapies, IUDs, be abstinent, or have a vasectomized partner) andwho have not added and/or changed the method of birth control in the last 6 months,and have no intention of adjusting or changing the method of birth control 5. Agreeto discontinue all agents used to treat hyperpigmentation, aging or exfoliate theskin during the course of the study. Makeup and moisturizers are permitted.

6. Agree not to change their sun exposure at work, home, or leisure and apply studysupplied sunscreen daily.

7. Technical ability and willingness to apply Investigational product. 8. Willing toallow digital photos of treatment and comparison areas to be taken and stored.

8. Willing to apply study-supplied mineral sunscreen, moisturizer, and cleanser to theface daily throughout the duration of the study

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded in the study:

1. Positive urine pregnancy test, pregnant, lactating, or female of childbearingpotential who does not agree to use an active method of birth control for theduration of the study.

2. Conditions at baseline that would interfere with evaluation of UV-tanned skin,especially other pigmentary disorders including, but not limited to vitiligoaffecting the treatment and comparison sites.

3. Severe photodamage as assessed by the 10-point photo damage assessment scale (Griffiths et al., 1992); (McKenzie et al., 2011).

4. Presence of known concomitant diseases associated with the development ofhyperpigmentation (e.g., thyroid, liver, adrenal).

5. Current tanning booth exposure or any kind of phototherapy within 3 months ofScreening.

6. Current or past use of monobenzyl ether to depigment skin.

7. Use of the following topical preparations within a 28-day washout period: topicalcorticosteroids, topical bleaching products (hyroquinone, niacinamide, kojic acid,ascorbic acid, chemical peels, topical tranexamic acid (TXA)), UV light therapy andsunbathing, topical retinoids.

8. Use of the following systemic agents within the specified washout periods:

9. Systemic corticosteroids (28 days) 2. Systemic cyclosporine, interferon (6 months)

10. Systemic acitretin, etretinate, isotretinoin (6 months) 4. Systemic methotrexate (6 months) 5. Systemic tranexamic acid (TXA) 6. Systemic photoallergic, phototoxic,and or photosensitizing drugs (6 months including psoralens, sulfonamide drugs,tetracycline antibiotics, thiazide diuretics, phenothiazines, coal tar andderivatives, and tricyclic antidepressants, chlorpromazine, benoxaprofen, piroxicam,nalidixic acid, procainamide, phenytoin, antimalarial medications, some cystostaticagents)

11. Laser (ablative or non-ablative), microneedling, PRP, or light-based treatment ofthe treatment areas within 3 months of Screening.

12. Any dermatological conditions within the designated application area that couldinterfere with clinical evaluations or any disease state or physical condition whichmight expose the subject to an unacceptable risk by study participation (neurodermatitis, eczema, psoriasis, atrophy, rosacea, seborrheic dermatits, etc.).

13. Any underlying disease(s) or other dermatological conditions that require the use ofexclusionary topical or systemic therapy (see Exclusion criteria 6, 7, and 8).

14. Known high daily exposure to the sun (>4 hours of sun exposure through work or dailyactivities) and/or frequent sunbathing/UV tanning.

15. Unwilling to discontinue applying any prescription or over the counter (OTC) topicalproduct creams and ointments, other than makeup and moisturizers, on treatmentarea(s) at Baseline through their last day of study.

16. Treatment of any type of cancer within 6 months of Screening, with the exception ofsuperficial skin cancers such as basal cell or squamous cell carcinoma outside oftreatment area.

17. Known allergy to any of the Investigational product(s) or any components in theInvestigational product(s) or history of hypersensitivity or allergic reactions toany of the study preparations as described in the Investigator's Brochure.

18. Unable to meet the study attendance requirements.

19. Any history of psychiatric disease or history of alcohol or drug abuse that wouldinterfere with the ability to comply with the study protocol.

20. Participation in any other trial of an investigational drug or device within 30 daysprior to enrollment or participation in a research study concurrent with this study.