A Study Comparing Two Topicals in the Treatment of Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:

A Randomized, Evaluator-Blinded, Bilateral Comparison Study of Two Topicals in the Treatment of Subjects With Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03743038
• Other study ID #: FX2018-23
• Status: Completed
• Phase: Phase 1
• Start date: November 20, 2018
• Est. completion date: February 11, 2019

Study information

• Verified date: March 2021
• Source: Foamix Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Randomized, Evaluator-Blinded, Bilateral Comparison Study to Evaluate the Safety and Efficacy of Two Topicals in the Treatment of Subjects With Acne Vulgaris (Study FX2018-23).

Description:

A Randomized, Evaluator-Blinded, Bilateral Comparison Study to Evaluate the Safety and Efficacy of Two Topicals in the Treatment of Subjects With Acne Vulgaris. Eligible subjects will be randomized (1:1) to treatment with Test Article A to one side of the face versus Test Article B on the contralateral side.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 11, 2019
• Est. primary completion date: February 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 40 Years

Eligibility

Inclusion Criteria:

• Has facial acne vulgaris with:

16 inflammatory lesions (papules, pustules) The inflammatory lesion count on the right and left side of the face should be similar IGA score of moderate (3) on both the right and left side of the face

Exclusion Criteria:

• Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations.

• More than two facial nodules/cysts

• Sunburn on the face

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• FMX101 vehicle
FMX101 vehicle - hydrophobic oil based vehicle (Test Article A)

Other:
• Hydro-alcohol solution
Hydro-alcohol solution based vehicle (Test Article B)

Locations

Country	Name	City	State
United States	Site #01	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Foamix Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With 0 to 4 Investigator's Global Assessment Score at Week 6	Severity of acne vulgaris was assessed by Investigator Global Assessment (IGA). The IGA score is a static evaluation of the overall severity or "average" degree of severity of a participant's disease by the Blinded Evaluator taking into account all of the participant's facial acne lesions as the participant appears on the day of the evaluation. Overall severity of acne was assessed using a five-point scale where 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Low score represented best outcome and higher score value indicated worst outcome.	At Week 6
Primary	Number of Participants Achieving Investigator's Global Assessments Treatment Success at Week 6	Severity of acne vulgaris was assessed by IGA. The IGA score is a static evaluation of the overall severity or "average" degree of severity of a participant's disease by the Blinded Evaluator taking into account all of the participant's facial acne lesions as the participant appears on the day of the evaluation. Overall severity of acne was assessed using a five-point scale where 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. The IGA treatment "success" was defined as at least a two-point improvement in IGA score relative to Baseline.	At Week 6
Primary	Absolute Change From Baseline to Week 6 in Inflammatory Lesion Count	Inflammatory lesion count (ILC) included papules (raised inflammatory lesions with no visible purulent material) and pustules (raised inflammatory lesions with visible purulent material).	Day 1/ Baseline and Week 6
Primary	Percentage Change From Baseline to Week 6 in Inflammatory Lesion Count	The ILC included papules (raised inflammatory lesions with no visible purulent material) and pustules (raised inflammatory lesions with visible purulent material).	Day 1/ Baseline and Week 6
Primary	Absolute Change From Baseline to Week 6 in Non-Inflammatory Lesion Count	The non-inflammatory lesion count (NILC) included open and closed comedones.	Day 1/ Baseline and Week 6
Primary	Percentage Change From Baseline to Week 6 in Non-Inflammatory Lesion Count	The NILC included open and closed comedones.	Day 1/ Baseline and Week 6
Primary	Change in Sebum Percentage Relative to Baseline Versus Weeks 2, 4, 6 and 7	Sebum measurement was conducted on the right and left side of the face. The sebum measurement represented the sebum score of saturation of the film and had a range of 0 to 99, where 99 equated to very oily skin.	Day 1/Baseline and Weeks 2, 4, 6 and 7
Primary	Change in Transepidermal Water Loss Relative to Baseline Versus Weeks 2, 4, 6 and 7	Transepidermal Water Loss (TEWL) was conducted on the right and left side of the face.	Day 1/Baseline and Weeks 2, 4, 6 and 7
Primary	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)	An adverse event is any untoward medical occurrence associated with the use of a drug in participants, whether or not considered drug related.	Day 1 until Week 7 (End of Study) and Unscheduled Visit
Primary	Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline	The local skin reactions (LSRs) included erythema, edema, scaling/dryness, burning/stinging, pruritus, erosion, and pain) were assessed. Erythema, edema, scaling/dryness, and erosion were assessed by the investigator and burning/stinging, pain, and pruritus were assessed by the participant. Assessments was made using a 4-point ordinal scale where 0=absent, 1=mild (slight, barely perceptible), 2=moderate (distinct presence), and 3=severe (marked, intense). Here, lower point represented no reaction and higher points represented severe reactions.The LSRs were assessed both before and 15 minutes following test article application.	Day 1 until Week 7 (End of Study) or Unscheduled Visit