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Sunscreen Test Code: V53-028 · 1 trial · 1 indication
Test material (V53-028 and V53-030) and control test material (8% Homoslate SPF 4) were applied to test area. Following exposure to a series of Ultraviolet light exposures, SPF scores were recorded at 16 to 24 hours post-exposure, to determine the Minimal Erythema Dose (MED) of protected and unprotected skin. SPF was calculated as the MED of protected skin divided by the MED of unprotected skin. Expected SPF 15 is a score on a scale; range 11.34 (worst) to 19.83 (best).
Test materials (V53-028 and V53-030) were applied to test area. Following a series of Ultraviolet radiation A (UVA) exposures, scores were recorded at 2 and 4 hours post-exposure, to determine the Minimal Persistent Pigment-Darkening Dose (MPPD) of protected and unprotected skin. PFA was calculated as the MPPD of protected skin divided by the MPPD of unprotected skin. Expected PFA is a score on a scale; range 6.40 (worst) to 15.62 (best).
| Arm | Type | Description |
|---|---|---|
| SPF Testing | EXPERIMENTAL | Following Food and Drug Administration (FDA) guidelines for SPF testing, exposure control and product-protected site erythema responses are scored after 16 to 24 hours post-exposure to full spectrum light (Ultraviolet B radiation \[UVB\] and UVA). |
| UVA Protection Testing | EXPERIMENTAL | Determination of Ultraviolet A Protection Factor (PFA). Following FDA guidelines, test sites exposed to UVA are scored for pigmentation responses 2 to 4 hours post-exposure. |
| Name | Type | Description |
|---|---|---|
| Sunscreen Test Code: V53-028 | DRUG | Sunscreen formula containing 15% Zinc Oxide, 3% Avobenzone, and 1% Ensulizole |
| Sunscreen Test Code: V53-030 | DRUG | Sunscreen formula containing 15% Zinc Oxide and 3% Avobenzone |
| Standard SPF 4 Sunscreen | DRUG | 8% Homosalate Standard SPF 4 Sunscreen |
Inclusion Criteria: * 18 to 70 years of age * Have Fitzpatrick skin types I, II, or III * In good general health based on a medical history review * Be free of any acute or chronic illness/disease that might interfere with or increase risk of study participation * Be able to cooperate with the inve...
V53-028 is an investigational small molecule being developed for sun protection. It is a sunscreen formula intended to protect the skin from sun damage. The drug is currently in Phase 3 clinical development, though it remains investigational and has not been approved by regulatory authorities.
V53-028 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded over-the-counter under the ticker symbol BAYRY. The company is conducting clinical trials to evaluate the safety and efficacy of this sunscreen product.
V53-028 is in Phase 3 clinical development. It is an investigational drug and has not yet received regulatory approval. The Phase 3 trial for this sunscreen formula has been completed, but the product remains under investigation and is not yet available to the public.
V53-028 has one completed Phase 3 clinical trial registered under NCT01001975, titled "Determination of Sun Protection in Sunscreen Formulas (Study SR09-15)(P08236)". The study enrolled 10 healthy adult volunteers and evaluated the sun protection provided by the sunscreen formula.
V53-028 is not FDA approved. It is an investigational drug currently in Phase 3 clinical development. While the Phase 3 trial has been completed, the product has not yet received approval from the FDA or any other regulatory authority and remains under investigation.