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This open-label, multi-center clinical trial was conducted to evaluate the dual skincare regimen of vitamin C serum and moisturizing sunscreen SPF 45 to improve facial hyperpigmentation and photodamage after 12 weeks of twice daily use in healthy female subjects between 35 - 60 years old. A total of 33 subjects completed study participation.
This open-label, multi-center clinical trial was conducted to evaluate the dual skincare regimen of vitamin C serum and moisturizing sunscreen SPF 45 to improve facial hyperpigmentation and photodamage when used twice daily over the course of 12 weeks by healthy women with Fitzpatrick skin type I - V, moderate to severe global face hyperpigmentation and moderate global face photodamage.
Efficacy and tolerability will be assessed through clinical grading at baseline, weeks 4, 8 and 12. Efficacy evaluation for hyperpigmentation (mottled), hyperpigmentation (discrete), overall photodamage, clarity/brightness, overall appearance, skin tone evenness (redness), fine lines and wrinkles. Investigator and subject tolerability, self-assessment questionnaire and clinical VISIA photography will be completed at baseline, weeks 4, 8 and 12. Subject testimonials will be completed at week 12.
A total of 33 subjects completed study participation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin C Serum and Moisturizing Sunscreen SPF 45 | Other | Dual Regimen: Vitamin C Serum Tinted Moisturizing Sunscreen SPF 45 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gentle Cleansing Lotion, Revision Skincare | Other | Gentle cleansing lotion to be used by study participants twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in clinical efficacy of hyperpigmentation versus Baseline | The primary efficacy endpoint will be the Investigator Clinical Grading using Modified Griffith's 10-point Scale. A change in scores at week 4, week 8 and week 12 in comparison to baseline indicates an improvement for the indicated parameter. Global facial hyperpigmentation will be assessed on each subject's face using a modified Griffiths' 10-point scale according to the following numerical definitions (half-point scores may be used as necessary to more accurately describe the skin condition): 0 = none (best possible condition); 1 to 3 = mild; 4 to 6 = moderate;7 to 9 = severe (worst possible condition). The lower the score equates to the best possible outcome. | 12 weeks |
| Lack of Significant Increase in Objective Investigator Tolerability Parameters at week 4, 8, 12 compared to Baseline | The primary tolerability endpoint will be favorable analysis of the Investigator Tolerability Assessment of Erythema, Edema and Dryness. A change in scores or lack of significant change at week 4, week 8 and week 12 in comparison to Baseline indicates tolerability/safety of the test material. Four point scale with a lower score indicating a better outcome. Example for Erythema: 0 = None No erythema of the treatment area, 1 = Mild Slight, but definite redness of the treatment area, 2 = Moderate Definite redness of the treatment area, 3 = Severe Marked redness of the treatment area | 12 weeks |
| Incidence and severity of adverse events | The primary safety endpoint will be determined by the incidence and severity of adverse events in healthy subjects through-out the length of the study. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in clinical efficacy of photodamage versus Baseline | The secondary efficacy endpoint will be the Investigator Clinical Grading using Modified Griffith's 10-point Scale. A change in scores at week 4, week 8 and week 12 in comparison to baseline indicates an improvement for the indicated parameter. Global facial photodamage will be assessed on each subject's face using a modified Griffiths' 10-point scale according to the following numerical definitions (half-point scores may be used as necessary to more accurately describe the skin condition): 0 = none (best possible condition); 1 to 3 = mild; 4 to 6 = moderate;7 to 9 = severe (worst possible condition). The lower the score equates to the best possible outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Art of Skin MD | Solana Beach | California | 92075 | United States | ||
| About Skin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37915337 | Derived | Hooper D, Tedaldi R, Iglesia S, Young MB, Kononov T, Zahr AS. Antioxidant Skincare Treatment for Hyperpigmented and Photodamaged Skin: Multi-Center, Open-Label, Cross-Seasonal Case Study. J Clin Aesthet Dermatol. 2023 Oct;16(10):31-38. |
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Prospective, Multi-Center, Open-Label 33 female subjects between 35 to 60 years old with Fitzpatrick skin type I-V, moderate to severe global face hyperpigmentation, and moderate global face photodamage.
Washout period of 2 weeks refraining from active antiaging topical products, including vitamin C, retinoids, peptides, and growth factors.
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| 12 weeks |
| Lack of Significant Increase in Objective Subject Tolerability Parameters at week 4, 8, 12 | The primary tolerability endpoint will be favorable analysis of the Subject Tolerability Assessment of Erythema, Edema and Dryness. A change in scores or lack of significant change at week 4, week 8 and week 12 in comparison to Baseline indicates tolerability/safety of the test material. Four point scale with a lower score indicating a better outcome. Example for Erythema: Erythema 0=None No erythema of the treatment area,1=Mild Slight, but definite redness of the treatment area, 2=Moderate Definite redness of the treatment area, 3=Severe Marked redness of the treatment area | 12 weeks |
| Greenwood Village |
| Colorado |
| 80111 |
| United States |
| Brian S. Biesman, M.D. | Nashville | Tennessee | 37203 | United States |
| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| ID | Term |
|---|---|
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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