Open-label, Single-arm, Proof of Concept Study in Subjects with Mild-to-moderate Facial Hyperpigm… (NCT06473974) | Clinical Trial Compass
WithdrawnPhase 2
Open-label, Single-arm, Proof of Concept Study in Subjects with Mild-to-moderate Facial Hyperpigmentation
Stopped: This study had been withdrawn by the sponsor as they are in process to approach FDA with rationale to get agency feedback and share written response on IRB query.
Thereafter, they may again approach with new application and FDA written response.
United States0Started 2025-01-01
Plain-language summary
This research study will test how well hyperpigmentation treatment works for subjects with mild-to-moderate facial hyperpigmentation. The study will also test if the hyperpigmentation treatment causes any irritation. For 12 weeks of the study, participants will use the assigned treatment, along with a provided cleanser and sunscreen.
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Willing and able to provide written informed consent for the study before the initiation of any study-specific procedures.
✓. Female or male aged 18-60 years (both inclusive), with Fitzpatrick skin types I-VI.
✓. Subjects with mild-to-moderate facial hyperpigmentation (including but not limited to melasma, PIH, solar lentigines, or dark spots, etc.) based on modified Griffiths 10-point scale.
✓. Affected areas include the forehead, cheeks (malar), nose, perioral area, and chin.
✓. Men who shaved regularly (at least three times weekly) with no beards will be allowed to participate.
✓. Subjects of all races and ethnicities including, but not limited to, Caucasian, African-American, Latino, Asian, Middle Eastern and East Indian will be enrolled for the present study.
✓. Subjects willing to sign have their photographs taken during the study and willing to sign a photography release.
✓. Willing to withhold 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.
Exclusion criteria
✕. Unwilling or unable to comply with scheduled visits, cosmetic product application plan, laboratory tests, or other study procedures and study restrictions.
✕. Subjects diagnosed with known allergies to study provided skin care products.
What they're measuring
1
Overall hyperpigmentation score using modified Griffiths 10-point scale.
✕. Subjects who are nursing, pregnant, or planning to become pregnant during the study according to subject self-report.
✕. Subjects with a history of skin cancer.
✕. Subjects having a health condition and/or pre-existing or dormant dermatologic disease on the face/planned treatment area (e.g. psoriasis, rosacea, acne, eczema, seborrheic dermatitis, severe excoriation) that the investigator or designee deems inappropriate for participation or could interfere with the outcome of the study.
✕. Subjects with facial plastic surgery or ablative laser resurfacing during the past year; non-ablative laser resurfacing, neurotoxins, or dermal fillers during the previous 3 months; superficial resurfacing treatment (chemical peels, microdermabrasion, micro-needling), neurotoxin or dermal fillers during the previous 6 weeks.
✕. Subjects with a history of immunosuppression/immune deficiency disorders \[including (HIV infection or AIDS) or currently using immunosuppressive medications (e.g. azathioprine, belimumab, cyclophosphamide, etanercept, adalimumab, mycophenolate mofetil, methotrexate, prednisone, infliximab, ustekinumab) and/or radiation as determined by study documentation that the investigator or designee deems inappropriate for participation or could interfere with the outcome of the study.
✕. Subjects with an uncontrolled disease such as asthma, diabetes, hypertension, hyperthyroidism, or hypothyroidism. Subjects having multiple health conditions may be excluded from participation even if the conditions are controlled by diet, medications, etc.