Photoallergy Clinical Trial
Official title:
A Randomized Study to Assess the Potential for Photoallergy of SPF 50 Y65 110, SPF 50 Y51 002 and SPF 15 V27 104 in Human Subjects
| NCT number | NCT02872220 |
| Other study ID # | 18291 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 23, 2015 |
| Est. completion date | May 8, 2015 |
| Verified date | December 2018 |
| Source | Bayer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The primary objective of this tudy was to evaluate the potential of photoallergy of of sun
care products Sun Protection Factor (SPF) 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104
application compared to that of a negative control (0.9% sodium chloride, NaCl) and followed
by irradiation with UV A and UVB.
The secondary objective aims for evaluation of the safety of SPF 50 Y65 110, SPF 50 Y51 002,
and SPF 15 V27 104 combined with ultraviolet (UV) A/B irradiation by monitoring adverse
events (AEs) throughout the study.
| Status | Completed |
| Enrollment | 56 |
| Est. completion date | May 8, 2015 |
| Est. primary completion date | May 8, 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Men or women, aged 18 to 65 with good general health - Fitzpatrick skin type I IV - Females (of childbearing potential) on acceptable measure of contraception - Willing to follow study rules, which include: no sun exposure (for example, no swimming, sunbathing, or tanning beds), avoidance of activities that would cause excessive sweating, no use of lotions, creams, or oils on the back area - Willing to not change the current brand of personal care products such as soaps, body washes, laundry detergent, body sprays, body spritzes, etc. while participating in the study |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Bayer |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluation of inflammatory responses | Inflammatory responses (Based on scores): 0 = No visible reaction + = Slight, confluent, or patchy erythema 1 = Mild erythema (pink) 2 = Moderate erythema (definite redness) 3 = Strong erythema (very intense redness) | up to 3 weeks | |
| Primary | Evaluation of superficial effects | Superficial effects: g = Glazing y = Peeling c = Scab, dried film of serous exudate of vesicular or bulla reaction d = Hyperpigmentation (reddish brown discoloration of test site) h = Hypopigmentation (loss of visible pigmentation at test site) f = Fissuring grooves in the superficial layers of the skin | up to 3 weeks | |
| Secondary | Adverse event collection as a measure of safety and tolerability | up to 3 weeks |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03812887 -
Photopatch Test Study (POST Study)
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| Completed |
NCT03899064 -
Evaluation of Potential Development of Photoallergic Skin Reaction After Use of MC2-01 Cream
|
Phase 1 |