Trial Outcomes & Findings for Adjunctive Usage of a Moisturizing Lotion (Cetaphil® Moisturizing Lotion) to Limit the Skin Irritation Linked to the Set-Up of a Treatment by Topical Retinoid (Differin® Gel 0,1%) in Healthy Subjects of Chinese Origins (NCT NCT00971282)

NCT ID: NCT00971282

Last Updated: 2021-02-18

Results Overview

score from 0 (none) to 3 (severe)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 30 participants
• Primary outcome timeframe: at 4 weeks
• Results posted on: 2021-02-18

Participant Flow

Participant milestones

Measure	Intra-individual Comparison Differin applied once daily (evening) on the whole face Cetaphil applied once daily (morning) on 1 side of the face
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Adjunctive Usage of a Moisturizing Lotion (Cetaphil® Moisturizing Lotion) to Limit the Skin Irritation Linked to the Set-Up of a Treatment by Topical Retinoid (Differin® Gel 0,1%) in Healthy Subjects of Chinese Origins

Baseline characteristics by cohort

Measure	Intra-individual Comparison n=30 Participants Differin applied once daily (evening) on the whole face Cetaphil applied once daily (morning) on 1 side of the face
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	39.9 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment Singapore	30 participants n=5 Participants

PRIMARY outcome

Timeframe: at 4 weeks

Population: safety population (APT)

score from 0 (none) to 3 (severe)

Outcome measures

Measure	Cetaphil + Differin n=30 Participants Differin applied once daily (evening) Cetaphil applied once daily (morning)	Differin Alone n=30 Participants Differin applied once daily (evening)
Erythema Rating Scale	0.6 units on a scale Standard Error 0.7	0.7 units on a scale Standard Error 0.7

PRIMARY outcome

Timeframe: at 4 weeks

Population: safety population (APT)

score from 0 (none) to 3 (severe)

Outcome measures

Measure	Cetaphil + Differin n=30 Participants Differin applied once daily (evening) Cetaphil applied once daily (morning)	Differin Alone n=30 Participants Differin applied once daily (evening)
Scaling	0.3 units on a scale Standard Error 0.6	0.6 units on a scale Standard Error 0.8

PRIMARY outcome

Timeframe: at 4 weeks

Population: safety population (APT)

score from 0 (none) to 3 (severe)

Outcome measures

Measure	Cetaphil + Differin n=30 Participants Differin applied once daily (evening) Cetaphil applied once daily (morning)	Differin Alone n=30 Participants Differin applied once daily (evening)
Dryness	0.3 units on a scale Standard Error 0.5	0.4 units on a scale Standard Error 0.6

PRIMARY outcome

Timeframe: at 4 weeks

Population: safety population (APT)

score from 0 (none) to 3 (severe)

Outcome measures

Measure	Cetaphil + Differin n=30 Participants Differin applied once daily (evening) Cetaphil applied once daily (morning)	Differin Alone n=30 Participants Differin applied once daily (evening)
Stinging/Burning	0.5 units on a scale Standard Error 0.6	0.6 units on a scale Standard Error 0.6

PRIMARY outcome

Timeframe: at 4 weeks

Population: safety population (APT)

score from 0 (none) to 3 (severe)

Outcome measures

Measure	Cetaphil + Differin n=30 Participants Differin applied once daily (evening) Cetaphil applied once daily (morning)	Differin Alone n=30 Participants Differin applied once daily (evening)
Pruritus	0.5 units on a scale Standard Error 0.6	0.6 units on a scale Standard Error 0.7

Adverse Events

Cetaphil + Differin

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Differin Alone

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Cetaphil + Differin n=30 participants at risk intra-individual comparison	Differin Alone n=30 participants at risk intra-individual comparison
Skin and subcutaneous tissue disorders dermatitis acneiform	13.3% 4/30 • Number of events 4 • 4 weeks All medical clinical events occurred after subject's consent signature and during the study, whether observed by the Evaluator/Injector or reported by the Subject and whether or not thought to be treatment-related were considered adverse events and collected.	6.7% 2/30 • Number of events 3 • 4 weeks All medical clinical events occurred after subject's consent signature and during the study, whether observed by the Evaluator/Injector or reported by the Subject and whether or not thought to be treatment-related were considered adverse events and collected.
Injury, poisoning and procedural complications excoriation	0.00% 0/30 • 4 weeks All medical clinical events occurred after subject's consent signature and during the study, whether observed by the Evaluator/Injector or reported by the Subject and whether or not thought to be treatment-related were considered adverse events and collected.	10.0% 3/30 • Number of events 3 • 4 weeks All medical clinical events occurred after subject's consent signature and during the study, whether observed by the Evaluator/Injector or reported by the Subject and whether or not thought to be treatment-related were considered adverse events and collected.
Skin and subcutaneous tissue disorders scab	6.7% 2/30 • Number of events 3 • 4 weeks All medical clinical events occurred after subject's consent signature and during the study, whether observed by the Evaluator/Injector or reported by the Subject and whether or not thought to be treatment-related were considered adverse events and collected.	3.3% 1/30 • Number of events 1 • 4 weeks All medical clinical events occurred after subject's consent signature and during the study, whether observed by the Evaluator/Injector or reported by the Subject and whether or not thought to be treatment-related were considered adverse events and collected.
Skin and subcutaneous tissue disorders skin exfoliation	10.0% 3/30 • Number of events 3 • 4 weeks All medical clinical events occurred after subject's consent signature and during the study, whether observed by the Evaluator/Injector or reported by the Subject and whether or not thought to be treatment-related were considered adverse events and collected.	13.3% 4/30 • Number of events 4 • 4 weeks All medical clinical events occurred after subject's consent signature and during the study, whether observed by the Evaluator/Injector or reported by the Subject and whether or not thought to be treatment-related were considered adverse events and collected.
Infections and infestations upper respiratory tract infection	6.7% 2/30 • Number of events 2 • 4 weeks All medical clinical events occurred after subject's consent signature and during the study, whether observed by the Evaluator/Injector or reported by the Subject and whether or not thought to be treatment-related were considered adverse events and collected.	6.7% 2/30 • Number of events 2 • 4 weeks All medical clinical events occurred after subject's consent signature and during the study, whether observed by the Evaluator/Injector or reported by the Subject and whether or not thought to be treatment-related were considered adverse events and collected.

Additional Information

Florence Paliargues

Galderma

Phone: 0033 4 92 95 29 57

Email: Florence.Paliargues@Galderma.com

Results disclosure agreements

• Principal investigator is a sponsor employee Any intent of the investigator to publish or disclose in any way the information requires the sponsor's prior written approval. The investigator shall provide their draft of such publication to sponsor for review and approval at least 2 months prior to the date of the intended publication. Sponsor shall have the absolute right to determine whether information may be published by the investigator.
• Publication restrictions are in place

Restriction type: OTHER