Evaluation of Topical Dutasteride as a Potential New Therapy for Facial Acne Vulgaris Versus the Triple Combination Therapy (Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel)

ConditionAcne Vulgaris
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University

About this trial

Acne vulgaris (AV) is one of the most prevalent dermatological conditions worldwide, affecting approximately 85% of adolescents and young adults between the ages of 12 and 24 years .While acne is often self-limiting, it can have profound psychosocial implications as individuals with acne are more likely to experience emotional distress, lower self-esteem and anxiety disorders .

Acne Vulgaris is a chronic inflammatory skin condition affecting the pilosebaceous units that leads to the development of different skin lesions such as comedones, papules, pustules, nodules and cystic lesions .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with facial acne vulgaris older than 18 years.

Disqualifiers

· Unrealistic expectations.

Unable to follow up.

Severe and nodulocystic AV.

Patients on topical treatment for AV (4 weeks before enrollment) and on systemic treatment for AV (3 months before enrollment).

Trial design

Design model

Parallel

Treatments tested in this trial

  • topical dutasteride

    Drug

    * Group I will be treated by topical Dutasteride 0.05% gel versus placebo (Petrolatum) (split face). * Group II will be treated by topical Dutasteride 0.05% gel versus topical triple fixed-dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% gel (split face).

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Topical Dutasteride 0.05% gel versus placebo (Petrolatum) (split face).Experimental treatment 1 intervention
Group B: Topical Dutasteride 0.05% gel versus topical triple fixed-dose combinationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Evaluate and compare the therapeutic efficacy (clinical, microbiological & psychological) of topical Dutasteride 0.05% versus topical fixed-dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% gel in patients with facial AV

o Total lesions count (TLC) (inflammatory lesions and noninflammatory lesions)

Time frame
16 weeks
2

Evaluate and compare the therapeutic efficacy (clinical, microbiological & psychological) of topical Dutasteride 0.05% versus topical fixed-dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% gel in patients with facial AV

o The investigator's global assessment (IGA) of acne severity grade modified to assess the half-face acne severity ; Treatment success will be defined as an Investigator's Global Assessment score of 0 (clear) or 1 (almost clear), and a 2-grade or greater improvement from baseline at week 12.

Time frame
12 weeks

Secondary outcomes

1

Addressing the safety profile of the two topical therapeutics

By recording side effects by daily diary specifying side effect (whether systemic or topical ,type,site and onset )

Time frame
12 weeks
2

Psychological effect of AV and its relation to therapeutic outcomes

Cardiff Acne Disability Index (CADI) will be assessed at first visit and at end of 12 week-study period

Time frame
12 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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