Clinical Trial on the Effects and Side Effects of ProOxy in the Treatment of Acne

Medivet

Status and phase: Completed; Phase 1

Conditions: Acne Vulgaris

Treatments: Drug: ProOxy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01682200

PaspaPharma-04

Details and patient eligibility

About

This study was conducted to determine the effects and side effects of ProOxy facial spray in the treatment of acne.

Full description

A study on the effects and side effects of ProOxy facial spray was done. Sixty people were selected and approved to participate in this study. Pictures of the face (frontal,left side and right side) were taken upon acceptance, during and after treatment at 4,8 and 12 weeks intervals.

Enrollment: 50 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• patients with acne on their faces only
• patients who are at least 18 years of age
• patients who have normal and disease free skin at the dorsal surface of the upper arm.
• patients who are willing to follow instructions on both the Patch Test Part one and Part Two procedures and to follow scheduled visits.

Exclusion Criteria

• patients with systemic illnesses(such as but not limited to heart disease, hypertension, diabetes, cancer, liver disease, kidney disease)
• patients with very dark skin color, Fitzpatrick skin type V-VI, who are prone to post=inflammatory hyperpigmentation.
• patients with intake of oral medications including glucocorticoids or any immuno-suppressants or who have undergone ultraviolet phototherapy for the past 2 weeks prior to the patch test.
• patients with history of contact dermatitis, dermatographism or anaphylaxis.
• patients with history of eczematous and inflammatory dermatitis, seborrheic dermatitis and psoriasis.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

ProOxy, Effects and Side Effects in treating acne

Experimental group

Description:

Patients are instructed to clean the face with ProOxy facial cleanser and then spray on the face wet enough but not dripping twice daily (upon waking up and before bedtime) for 3 months.

Treatment:

Drug: ProOxy