Moisturizer Containing Licochalcone A, Decanediol, L-carnitine and Salicylic Acid in Reducing Relapsing of Acne

• Status: Recruiting
• Trial end date: 2020-08-01
• Target enrollment: 50
• Participant gender: All

Summary

Eucerin ProACNE® with the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid may be beneficial in alternative treatment of acne in maintenance phase. This study aims to evaluate the efficacy and safety of Eucerin ProACNE® with the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid during the maintenance phase of acne in Thai patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mahidol University
• Collaborator: Beiersdorf
• Treatments: Salicylates; Salicylic Acid

Criteria

Inclusion Criteria:

1. Patients who had age more than 18 years

2. Female patients must use any reliable contraceptive methods except contraceptive pills for at least 1 month prior to the study and 6 months after the completion of the study

3. Being diagnosed acne vulgaris by dermatologist. Patients will be clinically diagnosed with acne vulgaris by dermatologists by presenting of noninflammatory open or closed comedones (blackheads and whiteheads) or inflammatory lesions, which may be papules, pustules, or nodules. Lesions are likely to occur in high concentration of sebaceous glands, for example, face, neck, chest, and back.

Inclusion criteria of induction phase

1. Patients who have mild to moderate severity of acne vulgaris according to IGA* (Investigator's Global Assessment) scale of FDA (Food and Drug Administration) at both cheek and diagnosed by dermatologists.

IGA* Scale for Acne Vulgaris 0= Clear skin with no inflammatory or noninflammatory lesions

1. rare non-inflammatory lesions with no more than one small inflammatory lesion

2. mild severity defines as some non-inflammatory lesions with no more than a few inflammatory lesions (papules/ pustules only, no nodular lesions)

3. moderate severity defines as up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion

4. moderate severity defines as up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion

5. Severe severity defines as up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions

Maintenance phase

1. Patients who have at least 50 percent reduction in numbers of acne vulgaris or at least 2 grade improvement according to IGA Grade from baseline

Exclusion Criteria:

1. Patients receive antibiotics, systemic treatment for acne such as isotretinoin or contraceptive pills, or spironolactone within 4 weeks prior to the study

2. Patients with active skin disease at face within 2 weeks prior to the study

3. Patients with an allergic to licochalcone A, decanediol, L-carnitine, or salicylic acid

4. Patients with severe and uncontrollable comorbidities

5. Pregnant or breastfeeding women

6. Patients with other types of acne apart from acne vulgaris

7. Patients with an allergic to oral doxycycline