N/A Completed N=66 Randomized Quadruple-blind Treatment

Comparing OTC Acne Treatment to Prescription Regimen

Acne vulgaris

Source: ClinicalTrials.gov NCT01237821 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2019

Primary outcomePrimary: Treatment Tolerability Assessment: Erythema — 0.3; 0.4; 0.6; 0.4 score on a scale

Summary

This research is being done to find out the safety and efficacy of two acne creams, Effaclar and Benzaclin when used twice daily with a topical retinoid. Effaclar and Benzaclin are FDA approved for the treatment of acne.

Outcome Measures

Outcome	Result	p-value
PRIMARY Treatment Tolerability Assessment: Erythema	0.3; 0.4; 0.6; 0.4; 0.3; 0.4	—
PRIMARY Treatment Tolerability Assessment: Edema	0.1; 0.1; 0.2; 0.2; 0.1; 0.2	—
PRIMARY Treatment Tolerability Assessment: Dryness	0.4; 0.2; 0.9; 0.7; 0.6; 0.3	—
PRIMARY Treatment Tolerability Assessment: Peeling	0.1; 0.0; 0.5; 0.6; 0.5; 0.3	—
PRIMARY Facial Skin Assessment: Skin Tone (Clarity)	5.3; 5.0; 4.6; 4.4; 4.1; 3.9	—
PRIMARY Facial Skin Assessment: Skin Smoothness	5.0; 4.9; 4.7; 4.5; 4.2; 3.5	—
PRIMARY Facial Skin Assessment: Skin Brightness	5.1; 4.6; 4.6; 4.1; 4.0; 3.6	—
PRIMARY Facial Skin Assessment: Appearance of Pores	4.6; 4.6; 4.3; 4.5; 4.1; 4.2	—
PRIMARY Facial Skin Assessment: Overall Appearance	5.1; 5.0; 4.7; 4.4; 4.3; 3.9	—
PRIMARY Facial Skin Assessment: Global Acne Assessment	3.4; 3.1; 3.1; 2.7; 2.5; 2.3	—
PRIMARY Facial Lesion Counts: Open Comedones	8.4; 8.3; 5.3; 4.8; 3.2; 3.6	—
PRIMARY Facial Lesion Counts: Closed Comedones	22.5; 23; 16.0; 14.8; 9.8; 13.7	—
PRIMARY Facial Lesion Counts: Papules	17.4; 15.7; 12.0; 9.0; 8.0; 6.6	—
PRIMARY Facial Lesion Counts: Pustules	3.6; 3.9; 2.3; 1.4; 1.4; 1.3	—
PRIMARY Facial Lesion Counts: Noninflammatory Lesions	30.9; 31.3; 21.3; 19.6; 13.0; 17.3	—
PRIMARY Facial Lesion Counts: Inflammatory Lesions	21.0; 19.6; 14.3; 10.4; 9.4; 7.9	—
PRIMARY Facial Lesion Counts: Total Lesion	51.9; 51.0; 35.6; 30.0; 22.5; 25.1	—
PRIMARY Subjective Tolerability of Irritation Assessment (Participant Assessed): Stinging	0.1; 0.0; 0.8; 0.8; 0.4; 0.4	—
PRIMARY Subjective Tolerability of Irritation Assessment (Participant Assessed): Tingling	0.1; 0.0; 0.8; 0.8; 0.4; 0.4	—
PRIMARY Subjective Tolerability of Irritation Assessment (Participant Assessed): Itching	0.2; 0.1; 0.5; 0.5; 0.4; 0.4	—
PRIMARY Subjective Tolerability of Irritation Assessment (Participant Assessed): Burning	0.2; 0.1; 1.1; 1.0; 0.6; 0.4	—

Eligibility Criteria

Inclusion Criteria:males and females ages 18-50, mild to moderate acne vulgaris with > or equal to 15 inflammatory lesions, > or equal to 20 non-inflammatory lesions, avoid excessive sun exposure or tanning beds throughout the study Exclusion Criteria:Participants who have another skin condition that will interfere with lesion counting or assessments

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01237821). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.