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

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00971282
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Duration (Months): 5
• Patients Per Site Per Month: 6

Study Details

Study Description

Brief Summary

This is a single-center study, randomized, Investigator/Evaluator-blinded bilateral (split-face) comparison.

The objective: To assess the benefit of the concomitant use of a Moisturizing Lotion in reducing the skin irritation induced by a adapalen gel treatment in Chinese Subjects.

Condition or Disease	Intervention/Treatment	Phase
Healthy Skin	Drug: adapalen 0.1%; Other: Cetaphil®	Phase 4

Detailed Description

The interest & relevance of the concomitant use of a non-comedogenic moisturizer in order to decrease retinoid irritation has already been demonstrated in Caucasian patients. Such interest of associating a moisturizer when Differin® gel is prescribed has not been demonstrated in Asian populations.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: 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
• Study Start Date: Dec 1, 2008
• Actual Primary Completion Date: Apr 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: intra-individual comparison	Drug: adapalen 0.1%; Intra-individual (split-face) comparison: Differin® 0.1% (whole face) will be applied once daily for 4 weeks. Visits will be conducted weekly for a maximum of 5 visits.; Other: Cetaphil®; Intra-individual (split-face) comparison: Cetaphil® (only one side of the face) will be applied once daily for 4 weeks. Visits will be conducted weekly for a maximum of 5 visits.

Outcome Measures

Primary Outcome Measures

1. Erythema Rating Scale [at 4 weeks]

   score from 0 (none) to 3 (severe)

2. Scaling [at 4 weeks]

   score from 0 (none) to 3 (severe)

3. Dryness [at 4 weeks]

   score from 0 (none) to 3 (severe)

4. Stinging/Burning [at 4 weeks]

   score from 0 (none) to 3 (severe)

5. Pruritus [at 4 weeks]

   score from 0 (none) to 3 (severe)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• male or female subjects of Chinese origins

• aged 21 years or older

• with healthy skin;

Exclusion Criteria:

• skin pigmentation which interferes with the reading of skin reactions

• with sunburn, eczema, atopic dermatitis, perioral dermatitis, or rosacea on the area to be treated

• with a washout period for the following topical treatment(s) Corticosteroids, oher anti-inflammatory drugs, retinoids

• with a washout period for the following systemic treatment(s): Medications that may increase photosensitivity, corticosteroids, anti-inflammatories, retinoids

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	national Skin Center	Singapore		Singapore

Sponsors and Collaborators

• Galderma R&D

Investigators

• Principal Investigator: Dr LEOW, National Skin Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT00971282
• Other Study ID Numbers: RD.03.SPR.29076
• First Posted: Sep 3, 2009
• Last Update Posted: Feb 18, 2021
• Last Verified: Apr 1, 2012

Study Results

Participant Flow

Arm/Group Title	Intra-individual Comparison
Arm/Group Description	Differin applied once daily (evening) on the whole face Cetaphil applied once daily (morning) on 1 side of the face
Period Title: Overall Study
STARTED	30
COMPLETED	30
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Intra-individual Comparison
Arm/Group Description	Differin applied once daily (evening) on the whole face Cetaphil applied once daily (morning) on 1 side of the face
Overall Participants	30
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	30 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.9 (11.8)
Sex: Female, Male (Count of Participants)
Female	20 66.7%
Male	10 33.3%
Region of Enrollment (participants) [Number]
Singapore	30 100%

Outcome Measures

1. Primary Outcome

Title	Erythema Rating Scale
Description	score from 0 (none) to 3 (severe)
Time Frame	at 4 weeks

Outcome Measure Data

Analysis Population Description

safety population (APT)

Arm/Group Title	Cetaphil + Differin	Differin Alone
Arm/Group Description	Differin applied once daily (evening) Cetaphil applied once daily (morning)	Differin applied once daily (evening)
Measure Participants	30	30
Mean (Standard Error) [units on a scale]	0.6 (0.7)	0.7 (0.7)

2. Primary Outcome

Title	Scaling
Description	score from 0 (none) to 3 (severe)
Time Frame	at 4 weeks

Outcome Measure Data

Analysis Population Description

safety population (APT)

Arm/Group Title	Cetaphil + Differin	Differin Alone
Arm/Group Description	Differin applied once daily (evening) Cetaphil applied once daily (morning)	Differin applied once daily (evening)
Measure Participants	30	30
Mean (Standard Error) [units on a scale]	0.3 (0.6)	0.6 (0.8)

3. Primary Outcome

Title	Dryness
Description	score from 0 (none) to 3 (severe)
Time Frame	at 4 weeks

Outcome Measure Data

Analysis Population Description

safety population (APT)

Arm/Group Title	Cetaphil + Differin	Differin Alone
Arm/Group Description	Differin applied once daily (evening) Cetaphil applied once daily (morning)	Differin applied once daily (evening)
Measure Participants	30	30
Mean (Standard Error) [units on a scale]	0.3 (0.5)	0.4 (0.6)

4. Primary Outcome

Title	Stinging/Burning
Description	score from 0 (none) to 3 (severe)
Time Frame	at 4 weeks

Outcome Measure Data

Analysis Population Description

safety population (APT)

Arm/Group Title	Cetaphil + Differin	Differin Alone
Arm/Group Description	Differin applied once daily (evening) Cetaphil applied once daily (morning)	Differin applied once daily (evening)
Measure Participants	30	30
Mean (Standard Error) [units on a scale]	0.5 (0.6)	0.6 (0.6)

5. Primary Outcome

Title	Pruritus
Description	score from 0 (none) to 3 (severe)
Time Frame	at 4 weeks

Outcome Measure Data

Analysis Population Description

safety population (APT)

Arm/Group Title	Cetaphil + Differin	Differin Alone
Arm/Group Description	Differin applied once daily (evening) Cetaphil applied once daily (morning)	Differin applied once daily (evening)
Measure Participants	30	30
Mean (Standard Error) [units on a scale]	0.5 (0.6)	0.6 (0.7)

Adverse Events

Time Frame	4 weeks
Adverse Event Reporting Description	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.
Arm/Group Title	Cetaphil + Differin		Differin Alone
Arm/Group Description	intra-individual comparison		intra-individual comparison
All Cause Mortality
	Cetaphil + Differin		Differin Alone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Cetaphil + Differin		Differin Alone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Cetaphil + Differin		Differin Alone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/30 (33.3%)		10/30 (33.3%)
Infections and infestations
upper respiratory tract infection	2/30 (6.7%)	2	2/30 (6.7%)	2
Injury, poisoning and procedural complications
excoriation	0/30 (0%)	0	3/30 (10%)	3
Skin and subcutaneous tissue disorders
dermatitis acneiform	4/30 (13.3%)	4	2/30 (6.7%)	3
scab	2/30 (6.7%)	3	1/30 (3.3%)	1
skin exfoliation	3/30 (10%)	3	4/30 (13.3%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.