NCT04006795

A Photoxicity and Photoallergy Study of a Developmental Face Cream, Serum and Lotion

Completed NA Results posted Last updated 13 August 2021

What this trial tests

NA trial testing Serum in Skin Care in 40 participants. Completed in 11 October 2019.

Timeline

28 August 2019

Primary endpoint
11 October 2019

11 October 2019

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	40
Start date	28 August 2019
Primary completion	11 October 2019
Estimated completion	11 October 2019
Sites	1 location across Brazil

Drugs / interventions tested

• Serum — full drug profile →
• Lotion
• Cream
• Normal Saline

Conditions studied

• Skin Care — all drugs for Skin Care →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 65, any sex, with Skin Care. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Photo-initiated Potential Sensitization Reaction Primary · Day 40

Scoring of patch test reactions was performed by blind evaluator as per International Contact Dermatitis Research Group (ICDRG) grading '- to +++',where '-':negative reaction;'?+':doubtful reaction(faint erythema only),'+':weak(non-vesicular) positive reaction(erythema, infiltration and possibly papules);'++':strong(vesicular) positive reaction (erythema,infiltration,papules,vesicles); '+++':extreme positive reaction (bullous reaction, intense erythema and infiltration, coalescing vesicles).Score range '- to +++' where '-' indicated no adverse reaction and '+++' indicated very strong adverse r

Group	Value	95% CI
Developmental Serum	0
Developmental Lotion	0
Developmental Cream	0
Negative Control	0

Percentage of Participants With a Photo-initiated Reaction (Score of '+' or Greater) Which is Not Considered Potential Sensitization Reaction Secondary · Day 40

Scoring of patch test reactions was performed by blind evaluator as per ICDRG grading '- to +++', where '-':negative reaction; '?+':doubtful reaction(faint erythema only),'+':weak(non-vesicular) positive reaction(erythema, infiltration and possibly papules);'++':strong(vesicular) positive reaction (erythema, infiltration, papules, vesicles);'+++':extreme positive reaction (bullous reaction, intense erythema and infiltration, coalescing vesicles).Score range '- to +++' where '-' indicated no adverse reaction and '+++' indicated very strong adverse reaction.Any positive reaction ('+' or greater)

Group	Value	95% CI
Developmental Serum	0
Developmental Lotion	0
Developmental Cream	1
Negative Control	0

Percentage of Participants With a Potential Sensitization Reaction Which is Not Considered Photo-initiated Secondary · Day 40

Scoring of patch test reactions was performed by blind evaluator as per ICDRG grading grading '- to +++', where '-':negative reaction; '?+':doubtful reaction(faint erythema only),'+':weak(non-vesicular) positive reaction(erythema, infiltration and possibly papules); '++':strong(vesicular) positive reaction (erythema, infiltration, papules and vesicles); '+++':extreme positive reaction (bullous reaction, intense erythema and infiltration, coalescing vesicles). Score range '- to +++' where '-' indicates no adverse reaction and '+++' indicates very strong adverse reaction.Any positive reaction (a

Group	Value	95% CI
Developmental Serum	0
Developmental Lotion	0
Developmental Cream	0
Negative Control	0

Percentage of Participants With a Non-photoinitiated Reaction (Score of '+' or Greater) Which is Not Considered Potential Sensitization Reaction Secondary · Day 40

Scoring of patch test reactions was performed by blind evaluator as per ICDRG grading grading '- to +++', where '-':negative reaction; '?+':doubtful reaction(faint erythema only),'+':weak(non-vesicular) positive reaction(erythema, infiltration and possibly papules); '++':strong(vesicular) positive reaction (erythema, infiltration, papules and vesicles); '+++':extreme positive reaction (bullous reaction, intense erythema and infiltration, coalescing vesicles). Score range '- to +++' where '-' indicates no adverse reaction and '+++' indicates very strong adverse reaction.Any positive reaction (a

Group	Value	95% CI
Developmental Serum	0
Developmental Lotion	0
Developmental Cream	0
Negative Control	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to Day 40. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Developmental Serum

Serious: 0/37 (0%)

Deaths: 0/37

Developmental Lotion

Serious: 0/37 (0%)

Deaths: 0/37

Developmental Cream

Serious: 0/37 (0%)

Deaths: 0/37

Negative Control

Serious: 0/37 (0%)

Deaths: 0/37

Overall Participants

Serious: 0/37 (0%)

Deaths: 0/37

Other adverse events (7 terms — click to expand)

Reaction	System	Developmental Serum	Developmental Lotion	Developmental Cream	Negative Control	Overall Participants
Gastroenteritis	Infections and infestations	—	—	—	—	—
Herpes virus infection	Infections and infestations	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—
Arthropod bite	Injury, poisoning and procedural complications	—	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—	—
Vaginal discharge	Reproductive system and breast disorders	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—

Data from ClinicalTrials.gov NCT04006795 adverse events section.

Sponsor's own description

The purpose of this study is to demonstrate the absence of sensitisation and irritation potential of a product when applied to the skin and exposed to ultraviolet (UV) radiation. Photo-sensitisation potential will primarily be evaluated through a subsequent semi-occluded application and UV exposure (challenge phase) after a 2-week rest period. Photo-irritation potential will primarily be evaluated through the repeated occluded application and UV exposure of the study products over 3 weeks (induction phase).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.