Trial Outcomes & Findings for A Clinical Study to Investigate the Dermal and Ocular Tolerance of a Developmental Cosmetic Facial Serum Formulation in Healthy Females With Sensitive Skin (NCT NCT03640832)

Last Updated: 2020-11-27

Results Overview

A qualified dermatologist visually assessed the signs and symptoms of cutaneous irritation for dermal erythema, dryness, scaling, and edema on a scale with a score range of 0 to 3, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. Cutaneous irritation total score = dermal score of erythema + dermal score of dryness + dermal score of scaling + dermal score of edema. Total possible score range is 0 to 12 (higher value indicated more cutaneous irritation). Change from baseline for 21 days of product use = total score at Day 21 minus total score at baseline. Participants with a unit change of greater than (\>) 1 in total score (TS) of cutaneous irritation from baseline to 21 days of product use, are reported in this outcome measure.

Recruitment status

COMPLETED

Study phase

Target enrollment

90 participants

Primary outcome timeframe

Baseline and Day 21

Results posted on

2020-11-27

Participant Flow

All the participants were enrolled from one center in Germany.

A total of 141 participants were screened for the study out of which 90 participants were enrolled and randomized to any of the 2 treatment arms. A total of 51 participants did not meet the study criteria and were not randomized. All 90 randomized participants completed the study.

Participant milestones

Participant milestones
Measure	Developmental Facial Serum (Test Product) Participants were randomized to topically (facial) apply Physiogel Developmental Facial Serum, twice daily (morning and evening) to the freshly cleansed skin before applying moisturizer up to 21 (+2) days	Physiogel Calming Relief Anti-redness Serum(Reference Product) Participants were randomized to topically (facial) apply Physiogel Calming Relief Anti-Redness Serum, twice daily (morning and evening) to the freshly cleansed skin before applying moisturizer up to 21 (+2) days
Overall Study STARTED	44	46
Overall Study COMPLETED	44	46
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Clinical Study to Investigate the Dermal and Ocular Tolerance of a Developmental Cosmetic Facial Serum Formulation in Healthy Females With Sensitive Skin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Developmental Facial Serum (Test Product) n=44 Participants Participants were randomized to topically (facial) apply Physiogel Developmental Facial Serum, twice daily (morning and evening) to the freshly cleansed skin before applying moisturizer up to 21 (+2) days	Physiogel Calming Relief Anti-redness Serum(Reference Product) n=46 Participants Participants were randomized to topically (facial) apply Physiogel Calming Relief Anti-Redness Serum, twice daily (morning and evening) to the freshly cleansed skin before applying moisturizer up to 21 (+2) days	Total n=90 Participants Total of all reporting groups
Dermatologist Assessment of Signs and Symptoms of Cutaneous Irritation Total Score at Baseline Baseline, TS= 4	2 Participants n=93 Participants	4 Participants n=4 Participants	6 Participants n=27 Participants
Dermatologist Assessment of Signs and Symptoms of Cutaneous Irritation Total Score at Baseline Baseline, TS= 4.5	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Age, Continuous	49.5 Years STANDARD_DEVIATION 10.05 • n=93 Participants	48.8 Years STANDARD_DEVIATION 11.84 • n=4 Participants	49.2 Years STANDARD_DEVIATION 10.95 • n=27 Participants
Sex: Female, Male Female	44 Participants n=93 Participants	46 Participants n=4 Participants	90 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Asian - South East Asian heritage	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized White - White/Caucasian/European heritage	43 Participants n=93 Participants	44 Participants n=4 Participants	87 Participants n=27 Participants
Race/Ethnicity, Customized Unknown or not reported	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Fitzpatrick Skin Type I - pale white skin	6 Participants n=93 Participants	4 Participants n=4 Participants	10 Participants n=27 Participants
Fitzpatrick Skin Type II - white skin	13 Participants n=93 Participants	23 Participants n=4 Participants	36 Participants n=27 Participants
Fitzpatrick Skin Type III - light brown skin	22 Participants n=93 Participants	17 Participants n=4 Participants	39 Participants n=27 Participants
Fitzpatrick Skin Type IV - moderate brown skin	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Dermatologist Assessment of Signs and Symptoms of Cutaneous Irritation Total Score at Baseline Baseline, total score(TS)= 1	11 Participants n=93 Participants	14 Participants n=4 Participants	25 Participants n=27 Participants
Dermatologist Assessment of Signs and Symptoms of Cutaneous Irritation Total Score at Baseline Baseline, TS= 1.5	16 Participants n=93 Participants	12 Participants n=4 Participants	28 Participants n=27 Participants
Dermatologist Assessment of Signs and Symptoms of Cutaneous Irritation Total Score at Baseline Baseline, TS= 2	7 Participants n=93 Participants	3 Participants n=4 Participants	10 Participants n=27 Participants
Dermatologist Assessment of Signs and Symptoms of Cutaneous Irritation Total Score at Baseline Baseline, TS= 2.5	1 Participants n=93 Participants	6 Participants n=4 Participants	7 Participants n=27 Participants
Dermatologist Assessment of Signs and Symptoms of Cutaneous Irritation Total Score at Baseline Baseline, TS= 3	5 Participants n=93 Participants	6 Participants n=4 Participants	11 Participants n=27 Participants
Dermatologist Assessment of Signs and Symptoms of Cutaneous Irritation Total Score at Baseline Baseline, TS= 3.5	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline and Day 21

Population: The Safety Population included all participants who received at least 1 dose of the study product (test or reference product).

Outcome measures

Outcome measures
Measure	Developmental Facial Serum (Test Product) n=44 Participants Participants were randomized to topically (facial) apply Physiogel Developmental Facial Serum, twice daily (morning and evening) to the freshly cleansed skin before applying moisturizer up to 21 (+2) days	Physiogel Calming Relief Anti-redness Serum(Reference Product) n=46 Participants Participants were randomized to topically (facial) apply Physiogel Calming Relief Anti-Redness Serum, twice daily (morning and evening) to the freshly cleansed skin before applying moisturizer up to 21 (+2) days
Number of Participants With a Unit Change of Greater Than (>) 1 in Signs and Symptoms of Cutaneous Irritation Total Scores From Baseline to 21 Days of Product Use	3 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and Day 21

Population: The Safety Population included all participants who received at least 1 dose of the study product (test or reference product).

A qualified ophthalmologist visually assessed the signs and symptoms of ocular irritation for ocular eczema of the eyelid, conjunctivitis, follicles and chemosis conjunctivae on a scale with a score range of 0 to 3, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. Ocular irritation total score = ocular score of eczema of the eyelid + ocular score of conjunctivitis + ocular score of follicles + ocular score of chemosis conjunctivae. Total possible score range is 0 to 12 (higher value indicated more ocular irritation). Change from baseline for 21 days of product use = total score at Day 21 minus total score at baseline. Participants with a unit change of \> 1 in total score of ocular irritation from baseline to 21 days of product use, are reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Developmental Facial Serum (Test Product) n=44 Participants Participants were randomized to topically (facial) apply Physiogel Developmental Facial Serum, twice daily (morning and evening) to the freshly cleansed skin before applying moisturizer up to 21 (+2) days	Physiogel Calming Relief Anti-redness Serum(Reference Product) n=46 Participants Participants were randomized to topically (facial) apply Physiogel Calming Relief Anti-Redness Serum, twice daily (morning and evening) to the freshly cleansed skin before applying moisturizer up to 21 (+2) days
Number of Participants With a Unit Change of >1 in Signs and Symptoms of Ocular Irritation Total Scores From Baseline to 21 Days of Product Use Baseline, TS= 0	44 Participants	46 Participants
Number of Participants With a Unit Change of >1 in Signs and Symptoms of Ocular Irritation Total Scores From Baseline to 21 Days of Product Use Change at Day 21, TS >1	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, 1-2 hours post first use, Day 21

Population: The Safety Population included all participants who received at least 1 dose of the study product (test or reference product).

Participants were instructed to self-assess any sensations of cutaneous discomfort for redness, dryness, stinging/burning, itching and tightness on a scale with a score range of 0 to 3, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. Participant self-assessment of cutaneous irritation total score = redness + dryness + itching + stinging/burning + tightness. Total possible score range is 0 to 15 (higher value indicated more cutaneous irritation). Change from baseline at 1-2 hours post first use = total score at 1 to 2 hours minus total score at baseline. Similarly, change from baseline for 21 days of product use = total score at Day 21 minus total score at baseline. Participants with a unit change of \>1 in total score of cutaneous irritation from baseline to 1-2 hours post first product use and 21 days of product use, are reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Developmental Facial Serum (Test Product) n=44 Participants Participants were randomized to topically (facial) apply Physiogel Developmental Facial Serum, twice daily (morning and evening) to the freshly cleansed skin before applying moisturizer up to 21 (+2) days	Physiogel Calming Relief Anti-redness Serum(Reference Product) n=46 Participants Participants were randomized to topically (facial) apply Physiogel Calming Relief Anti-Redness Serum, twice daily (morning and evening) to the freshly cleansed skin before applying moisturizer up to 21 (+2) days
Number of Participants With a Unit Change of >1 in Signs and Symptoms of Cutaneous Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use Baseline, TS= 1	3 Participants	1 Participants
Number of Participants With a Unit Change of >1 in Signs and Symptoms of Cutaneous Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use Baseline, TS= 1.5	1 Participants	4 Participants
Number of Participants With a Unit Change of >1 in Signs and Symptoms of Cutaneous Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use Baseline, TS= 2	3 Participants	4 Participants
Number of Participants With a Unit Change of >1 in Signs and Symptoms of Cutaneous Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use Baseline, TS= 2.5	2 Participants	6 Participants
Number of Participants With a Unit Change of >1 in Signs and Symptoms of Cutaneous Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use Baseline, TS= 3	8 Participants	2 Participants
Number of Participants With a Unit Change of >1 in Signs and Symptoms of Cutaneous Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use Baseline, TS= 3.5	1 Participants	3 Participants
Number of Participants With a Unit Change of >1 in Signs and Symptoms of Cutaneous Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use Baseline, TS= 4	6 Participants	9 Participants
Number of Participants With a Unit Change of >1 in Signs and Symptoms of Cutaneous Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use Baseline, TS= 4.5	4 Participants	3 Participants
Number of Participants With a Unit Change of >1 in Signs and Symptoms of Cutaneous Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use Baseline, TS= 5	5 Participants	4 Participants
Number of Participants With a Unit Change of >1 in Signs and Symptoms of Cutaneous Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use Baseline, TS= 5.5	1 Participants	0 Participants
Number of Participants With a Unit Change of >1 in Signs and Symptoms of Cutaneous Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use Baseline, TS= 6	3 Participants	2 Participants
Number of Participants With a Unit Change of >1 in Signs and Symptoms of Cutaneous Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use Baseline, TS= 6.5	0 Participants	2 Participants
Number of Participants With a Unit Change of >1 in Signs and Symptoms of Cutaneous Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use Baseline, TS= 7	0 Participants	2 Participants
Number of Participants With a Unit Change of >1 in Signs and Symptoms of Cutaneous Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use Baseline, TS= 7.5	1 Participants	0 Participants
Number of Participants With a Unit Change of >1 in Signs and Symptoms of Cutaneous Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use Baseline, TS= 8	1 Participants	3 Participants
Number of Participants With a Unit Change of >1 in Signs and Symptoms of Cutaneous Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use Baseline, TS= 9	2 Participants	1 Participants
Number of Participants With a Unit Change of >1 in Signs and Symptoms of Cutaneous Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use Baseline, TS= 10	2 Participants	0 Participants
Number of Participants With a Unit Change of >1 in Signs and Symptoms of Cutaneous Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use Baseline, TS= 12	1 Participants	0 Participants
Number of Participants With a Unit Change of >1 in Signs and Symptoms of Cutaneous Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use Change at 1-2 hours, TS >1	3 Participants	4 Participants
Number of Participants With a Unit Change of >1 in Signs and Symptoms of Cutaneous Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use Change at Day 21, TS >1	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, 1-2 hours post first use, Day 21

Population: The Safety Population included all participants who received at least 1 dose of the study product (test or reference product).

Participants were instructed to self-assess any sensations of ocular discomfort for redness, dryness, stinging/burning and itching on a scale with a score range of 0 to 3, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. Participant self-assessment of ocular irritation total score = redness + dryness + itching + stinging/burning. Total possible score range is 0 to 12 (higher value indicated more ocular irritation). Change from baseline at 1-2 hours post first use = total score at 1 to 2 hours minus total score at baseline. Similarly, change from baseline for 21 days of product use = total score at Day 21 minus total score at baseline. Participants with a change of \> 1 in total score of ocular irritation from baseline to 1-2 hours post first product use and Day 21 days of product use, are reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Developmental Facial Serum (Test Product) n=44 Participants Participants were randomized to topically (facial) apply Physiogel Developmental Facial Serum, twice daily (morning and evening) to the freshly cleansed skin before applying moisturizer up to 21 (+2) days	Physiogel Calming Relief Anti-redness Serum(Reference Product) n=46 Participants Participants were randomized to topically (facial) apply Physiogel Calming Relief Anti-Redness Serum, twice daily (morning and evening) to the freshly cleansed skin before applying moisturizer up to 21 (+2) days
Number of Participants With a Unit Change of >1 in Signs and Symptoms of Ocular Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use Baseline, TS= 0	23 Participants	22 Participants
Number of Participants With a Unit Change of >1 in Signs and Symptoms of Ocular Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use Baseline, TS= 0.5	10 Participants	6 Participants
Number of Participants With a Unit Change of >1 in Signs and Symptoms of Ocular Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use Baseline, TS= 1	3 Participants	8 Participants
Number of Participants With a Unit Change of >1 in Signs and Symptoms of Ocular Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use Baseline, TS= 1.5	4 Participants	5 Participants
Number of Participants With a Unit Change of >1 in Signs and Symptoms of Ocular Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use Baseline, TS= 2	1 Participants	3 Participants
Number of Participants With a Unit Change of >1 in Signs and Symptoms of Ocular Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use Baseline, TS= 2.5	1 Participants	1 Participants
Number of Participants With a Unit Change of >1 in Signs and Symptoms of Ocular Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use Baseline, TS= 4	1 Participants	0 Participants
Number of Participants With a Unit Change of >1 in Signs and Symptoms of Ocular Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use Baseline, TS= 6	1 Participants	0 Participants
Number of Participants With a Unit Change of >1 in Signs and Symptoms of Ocular Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use Baseline, TS= 6.5	0 Participants	1 Participants
Number of Participants With a Unit Change of >1 in Signs and Symptoms of Ocular Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use Change at 1-2 hours, TS >1	0 Participants	0 Participants
Number of Participants With a Unit Change of >1 in Signs and Symptoms of Ocular Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use Change at Day 21, TS >1	1 Participants	1 Participants

Adverse Events

Developmental Facial Serum (Test Product)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Physiogel Calming Relief Anti-redness Serum(Reference Product)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Developmental Facial Serum (Test Product) n=44 participants at risk Participants were randomized to topically (facial) apply Physiogel Developmental Facial Serum, twice daily (morning and evening) to the freshly cleansed skin before applying moisturizer up to 21 (+2) days	Physiogel Calming Relief Anti-redness Serum(Reference Product) n=46 participants at risk Participants were randomized to topically (facial) apply Physiogel Calming Relief Anti-Redness Serum, twice daily (morning and evening) to the freshly cleansed skin before applying moisturizer up to 21 (+2) days
Eye disorders Chalazion	0.00% 0/44 • up to 21 (+2) days The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) that occurred on or after the first product application. One participant might have experienced more than one AE during the study. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.	2.2% 1/46 • up to 21 (+2) days The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) that occurred on or after the first product application. One participant might have experienced more than one AE during the study. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
Eye disorders Eye paraesthesia	0.00% 0/44 • up to 21 (+2) days The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) that occurred on or after the first product application. One participant might have experienced more than one AE during the study. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.	2.2% 1/46 • up to 21 (+2) days The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) that occurred on or after the first product application. One participant might have experienced more than one AE during the study. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
Eye disorders Eye pruritus	2.3% 1/44 • up to 21 (+2) days The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) that occurred on or after the first product application. One participant might have experienced more than one AE during the study. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.	0.00% 0/46 • up to 21 (+2) days The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) that occurred on or after the first product application. One participant might have experienced more than one AE during the study. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
Infections and infestations Nasopharyngitis	6.8% 3/44 • up to 21 (+2) days The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) that occurred on or after the first product application. One participant might have experienced more than one AE during the study. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.	0.00% 0/46 • up to 21 (+2) days The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) that occurred on or after the first product application. One participant might have experienced more than one AE during the study. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
Injury, poisoning and procedural complications Arthropod bite	2.3% 1/44 • up to 21 (+2) days The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) that occurred on or after the first product application. One participant might have experienced more than one AE during the study. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.	0.00% 0/46 • up to 21 (+2) days The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) that occurred on or after the first product application. One participant might have experienced more than one AE during the study. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
Musculoskeletal and connective tissue disorders Jaw cyst	0.00% 0/44 • up to 21 (+2) days The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) that occurred on or after the first product application. One participant might have experienced more than one AE during the study. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.	2.2% 1/46 • up to 21 (+2) days The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) that occurred on or after the first product application. One participant might have experienced more than one AE during the study. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/44 • up to 21 (+2) days The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) that occurred on or after the first product application. One participant might have experienced more than one AE during the study. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.	2.2% 1/46 • up to 21 (+2) days The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) that occurred on or after the first product application. One participant might have experienced more than one AE during the study. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
Musculoskeletal and connective tissue disorders Neck pain	2.3% 1/44 • up to 21 (+2) days The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) that occurred on or after the first product application. One participant might have experienced more than one AE during the study. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.	0.00% 0/46 • up to 21 (+2) days The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) that occurred on or after the first product application. One participant might have experienced more than one AE during the study. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
Nervous system disorders Headache	0.00% 0/44 • up to 21 (+2) days The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) that occurred on or after the first product application. One participant might have experienced more than one AE during the study. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.	6.5% 3/46 • up to 21 (+2) days The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) that occurred on or after the first product application. One participant might have experienced more than one AE during the study. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
Reproductive system and breast disorders Dysmenorrhoea	2.3% 1/44 • up to 21 (+2) days The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) that occurred on or after the first product application. One participant might have experienced more than one AE during the study. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.	0.00% 0/46 • up to 21 (+2) days The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) that occurred on or after the first product application. One participant might have experienced more than one AE during the study. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
Respiratory, thoracic and mediastinal disorders Nasal discomfort	2.3% 1/44 • up to 21 (+2) days The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) that occurred on or after the first product application. One participant might have experienced more than one AE during the study. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.	0.00% 0/46 • up to 21 (+2) days The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) that occurred on or after the first product application. One participant might have experienced more than one AE during the study. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
Skin and subcutaneous tissue disorders Acne	6.8% 3/44 • up to 21 (+2) days The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) that occurred on or after the first product application. One participant might have experienced more than one AE during the study. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.	2.2% 1/46 • up to 21 (+2) days The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) that occurred on or after the first product application. One participant might have experienced more than one AE during the study. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/44 • up to 21 (+2) days The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) that occurred on or after the first product application. One participant might have experienced more than one AE during the study. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.	2.2% 1/46 • up to 21 (+2) days The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) that occurred on or after the first product application. One participant might have experienced more than one AE during the study. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
Skin and subcutaneous tissue disorders Skin burning sensation	0.00% 0/44 • up to 21 (+2) days The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) that occurred on or after the first product application. One participant might have experienced more than one AE during the study. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.	2.2% 1/46 • up to 21 (+2) days The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) that occurred on or after the first product application. One participant might have experienced more than one AE during the study. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/44 • up to 21 (+2) days The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) that occurred on or after the first product application. One participant might have experienced more than one AE during the study. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.	2.2% 1/46 • up to 21 (+2) days The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) that occurred on or after the first product application. One participant might have experienced more than one AE during the study. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.