Comparison of Topical Clascoterone and Adapalene for Mild Acne Vulgaris

ConditionAcne Vulgaris
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age12-35
SponsorKhyber Teaching Hospital

About this trial

There is no local data available regarding the comparative efficacy of topical clascoterone and topical adapalene, particularly in patients with mild acne vulgaris. The findings of this study will help dermatologists identify the more effective topical treatment for mild acne vulgaris, leading to improved patient outcomes and better utilization of healthcare resources. Furthermore, the study will contribute local data to the existing literature and may assist in developing evidence-based treatment recommendations for patients with mild acne vulgaris in our setting.

Patients meeting the inclusion criteria from the Dermatology Unit, Khyber Teaching Hospital, MTI, Peshawar will be incorporated into the study following approval from the ethics committee. At the commencement of the trial, baseline demographics including gender, age, height, weight, BMI, duration of acne, socioeconomic status, profession, monthly income, education level and residential status will be documented. An elaborate explanation of the process involved in the study will be provided to the participants, and consent will be taken following an explanation of the pros and cons involved.

Randomization will be performed by computer generated random list. The group assignments will be put into sealed envelopes, which will be opened when the patient will be included in study. 30 patients will be in topical clascoterone group (A) while 30 patients will be in topical adapalene group (B).

Patients allocated to Group A will receive topical clascoterone 1% cream. It is required that they will clean their faces using a mild cleansing agent, dry their faces and thereafter apply a thin coating of clascoterone 1% cream to their whole face area in the morning and evening for 12 consecutive weeks.

Patients allocated to Group B will receive topical adapalene 0.1% gel. Patients will cleanse the skin using a gentle cleanser, allow it to dry in the air for 10 minutes, and then apply one pea-sized amount of 0.1% adapalene gel over their entire affected area of the face once a day before going to bed for 12 weeks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical diagnosis of mild acne vulgaris as per operational definition

Male or female patients

Age 12 to 35 years

Disqualifiers

History of acne conglobata

History of acne fulminans

Use of topical anti-acne medications within the last 4 weeks

Use of systemic anti-acne therapy within the last 12 weeks

Trial design

Design model

Single group

Treatments tested in this trial

  • Clascoterone Cream 1%

    Drug

    Participants in this group will apply topical clascoterone 1% cream to the affected areas as prescribed for the duration of the study.

  • Adapalene 0,1% cgel

    Drug

    Participants in this group will apply topical adapalene 0.1% gel to the affected areas as prescribed for the duration of the study.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: topical CLASCOTERONE 1 percent creamExperimental treatment 2 interventions
Group B: Topical adapalene 0.1 percent gelActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

IGA achievement

investigator global assessment achievement of 0 which is clear face or 1 which is almost clear

Time frame
Baseline to 12 Weeks Participants will be assessed at baseline and at 12 weeks following initiation of treatment. Efficacy will be determined by the change in acne lesion counts and clinical improvement from baseline to week 12.
2

Achievement of and IGA score of 0(clear) or 1(almost clear) after 12 weeks of treatment

Investigator global assessment scoring

Time frame
Baseline to 12 Weeks Participants will be assessed at baseline and at 12 weeks following initiation of treatment. Efficacy will be determined by the change in acne lesion counts and clinical improvement from baseline to week 12.

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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