Trial Outcomes & Findings for A Treatment Regimen for Student Athletes With Mild to Moderate Acne Vulgaris (NCT NCT02249104)

NCT ID: NCT02249104

Last Updated: 2022-08-23

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 28 participants
• Primary outcome timeframe: Baseline and 8 weeks
• Results posted on: 2022-08-23

Participant Flow

First subject, first visit: 20 Aug 2014; Single center study

Participant milestones

Measure	Acne Treatment Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily Cetaphil Acne Regimen: Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application Cetaphil® DermaControl™ Foam Wash, at least twice daily Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect
Overall Study STARTED	28
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Treatment Regimen for Student Athletes With Mild to Moderate Acne Vulgaris

Baseline characteristics by cohort

Measure	Acne Treatment n=28 Participants Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily Cetaphil Acne Regimen: Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application Cetaphil® DermaControl™ Foam Wash, at least twice daily Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect
Age, Categorical <=18 years	27 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 8 weeks

Outcome measures

Measure

Acne Treatment n=28 Participants Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily Cetaphil Acne Regimen: Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application Cetaphil® DermaControl™ Foam Wash, at least twice daily Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect

Mean Change From Baseline in Total Lesion Count

-26.9 Lesions counted Standard Deviation 25.3

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Outcome measures

Measure

Acne Treatment n=28 Participants Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily Cetaphil Acne Regimen: Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application Cetaphil® DermaControl™ Foam Wash, at least twice daily Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect

Percent Change From Baseline in Total Lesion Count

-29.6 Percent change Standard Deviation 26.9

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Outcome measures

Measure

Acne Treatment n=28 Participants Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily Cetaphil Acne Regimen: Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application Cetaphil® DermaControl™ Foam Wash, at least twice daily Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect

Mean Change From Baseline in Inflammatory Lesion Count

-10.8 Lesions counted Standard Deviation 9.1

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Outcome measures

Measure

Acne Treatment n=28 Participants Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily Cetaphil Acne Regimen: Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application Cetaphil® DermaControl™ Foam Wash, at least twice daily Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect

Mean Change From Baseline in Non-inflammatory Lesion Count

-16.3 Lesions counted Standard Deviation 20.5

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Outcome measures

Measure

Acne Treatment n=28 Participants Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily Cetaphil Acne Regimen: Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application Cetaphil® DermaControl™ Foam Wash, at least twice daily Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect

Percent Change From Baseline in Inflammatory Lesion Count

-35.7 Percent change Standard Deviation 29.9

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Outcome measures

Measure

Acne Treatment n=28 Participants Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily Cetaphil Acne Regimen: Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application Cetaphil® DermaControl™ Foam Wash, at least twice daily Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect

Percent Change From Baseline in Non-inflammatory Lesion Count

-27.1 Percent change Standard Deviation 34.4

Adverse Events

Acne Treatment

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Acne Treatment n=28 participants at risk Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily Cetaphil Acne Regimen: Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application Cetaphil® DermaControl™ Foam Wash, at least twice daily Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect
Skin and subcutaneous tissue disorders Erythema	14.3% 4/28 • Number of events 4 • 8 weeks
Skin and subcutaneous tissue disorders Dry skin	25.0% 7/28 • Number of events 7 • 8 weeks
Skin and subcutaneous tissue disorders Skin exfoliation	17.9% 5/28 • Number of events 5 • 8 weeks
Skin and subcutaneous tissue disorders Skin burning sensation	3.6% 1/28 • Number of events 1 • 8 weeks
Injury, poisoning and procedural complications Sunburn	3.6% 1/28 • Number of events 1 • 8 weeks
General disorders Application site pain	3.6% 1/28 • Number of events 1 • 8 weeks
Injury, poisoning and procedural complications Concussion	3.6% 1/28 • Number of events 1 • 8 weeks
Injury, poisoning and procedural complications Contusion	3.6% 1/28 • Number of events 1 • 8 weeks
Injury, poisoning and procedural complications Excoriation	3.6% 1/28 • Number of events 2 • 8 weeks
Injury, poisoning and procedural complications Ligament sprain	3.6% 1/28 • Number of events 1 • 8 weeks
Infections and infestations Ear infection	3.6% 1/28 • Number of events 1 • 8 weeks
Infections and infestations External ear cellulitis	3.6% 1/28 • Number of events 1 • 8 weeks
Immune system disorders Gastroenteritis viral	3.6% 1/28 • Number of events 1 • 8 weeks
Immune system disorders Seasonal allergy	7.1% 2/28 • Number of events 2 • 8 weeks
Respiratory, thoracic and mediastinal disorders Cough	3.6% 1/28 • Number of events 1 • 8 weeks
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.6% 1/28 • Number of events 1 • 8 weeks

Additional Information

Dr. Jay Mashburn

Galderma Laboratories L.P.

Phone: 817 961 5027

Email: jay.mashburn@galderma.com

Results disclosure agreements

• Principal investigator is a sponsor employee Investigator may publish, present, or use any results that do not disclose any confidential information furnished by Galderma. The investigator shall provide their draft of such publication to sponsor for review and approval at least 45 days prior to the date of the intended publication. Upon written request from Galderma, within the forty-five (45) day review period, the investigator will delay the publication or presentation for a maximum of an additional one-hundred eighty (180) days.
• Publication restrictions are in place

Restriction type: OTHER